PHA MSDS - ROGAINE(R) EXTRA STRENGTH
1PHARMACIA Print Date: December 05, 2001
Revision Date: December 10, 1999
Agent Id#: 55188
Page: 1 of 4
**** MATERIAL SAFETY DATA SHEET ****
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
COMMON NAME: ROGAINE(R) EXTRA STRENGTH
SYNONYMS: Minoxidil topical solution, 5 %
450588 - EDP NUMBER
MOLECULAR FORMULA: MIXTURE
CHEMICAL FAMILY: Mixture
USE: Human drug used for the treatment of diffuse thinning or hair loss.
MANUFACTURER/SUPPLIER: PHARMACIA & UPJOHN CO., A SUBSIDIARY OF
PHARMACIA CORP.
7171 PORTAGE RD
KALAMAZOO, MI 49001-0199
TELEPHONE NUMBERS: (269) 833-5122 - (24 HOURS)
(269) 833-7555 - (8:00 a.m. - 4:30 p.m.)
2. COMPOSITION/INFORMATION ON INGREDIENTS
INGREDIENT 1
COMMON NAME: Propylene Glycol USP
% BY WEIGHT: 50 %
CAS NUMBER: 57-55-6
EXPOSURE LIMIT(S):
AIHA WEEL-TWA: 50 PPM
INGREDIENT 2
COMMON NAME: Ethyl alcohol
% BY WEIGHT: 32 % (approximately)
EXPOSURE LIMIT(S):
OSHA PEL-TWA: 1,000 PPM
ACGIH TLV-TWA: 1,000 PPM
INGREDIENT 3
COMMON NAME: Water
% BY WEIGHT: 13 % (approximately)
CAS NUMBER: 7732-18-5
EXPOSURE LIMIT(S): Not established.
INGREDIENT 4
COMMON NAME: Minoxidil
% BY WEIGHT: 5 %
CAS NUMBER: 38304-91-5
EXPOSURE LIMIT(S):
PHARMACIA & UPJOHN EXPOSURE LIMIT-TWA: 1 UG/M3
EXPOSURE LIMIT(S) FOR THE MATERIAL: Not established.
3. HAZARDS IDENTIFICATION
PRIMARY ROUTE(S) OF EXPOSURE: Skin contact, eye contact, ingestion and
inhalation.
EFFECTS OF OVEREXPOSURE: Topical overexposure to Rogaine may cause irritant
1PHARMACIA Print Date: December 05, 2001
Revision Date: December 10, 1999
Agent Id#: 55188
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PHA MSDS - ROGAINE(R) EXTRA STRENGTH
**** MATERIAL SAFETY DATA SHEET ****
dermatitis and allergic contact dermatitis. The product contains an alcohol
base which will cause burning and irritation to the eyes. Systemic
overexposure may cause cardiovascular effects associated with tachycardia
(increased heart rate) and fluid retention.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Exposure to this product is
contraindicated in people with a history of hypersensitivity to any
ingredient in the preparation or in people with a history of liver disease.
4. FIRST AID MEASURES
EYES: Rinse immediately with plenty of water, also under the eyelids, for at
least 15 minutes.
SKIN: Wash off with soap and water. Take off all contaminated clothing
immediately.
INHALATION: Move to fresh air.
INGESTION: Contact a physician or poison control center.
5. FIRE FIGHTING MEASURES
FLASH POINT: 29 C (84 F)
LOWER EXPLOSION LIMIT (LEL): 3.3 % (ethanol)
UPPER EXPLOSION LIMIT (UEL): 19 % (ethanol)
EXTINGUISHING MEDIA: Water, carbon dioxide, or dry chemical.
FIRE-FIGHTING PROCEDURES: Wear self-contained breathing apparatus and full body
protective equipment.
UNUSUAL FIRE OR EXPLOSION HAZARDS: None.
HAZARDOUS COMBUSTION PRODUCTS: Carbon monoxide. Carbon dioxide. Nitrogen oxides
6. ACCIDENTAL RELEASE MEASURES
STEPS TO BE TAKEN IN CASE MATERIAL IS RELEASED OR SPILLED: Provide ventilation
and respiratory, skin and eye protection to prevent overexposure. Keep the
product out of drains; prevent entry to surface water, groundwater and soil.
Small spills should be absorbed with paper towels or other appropriate media.
Large spills can be vacuumed or scooped and placed in a suitable container.
All ignition sources should be removed.
7. HANDLING AND STORAGE
PRECAUTIONS FOR HANDLING AND STORING: As product is flammable, keep away from
heat, sparks and fire. Keep the container closed. Avoid contact with skin,
eyes and clothing. Wash thoroughly after handling. Launder contaminated
clothes before reuse. Store in a cool, dry place and protect from light.
Keep out of the reach of children.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
RESPIRATORY PROTECTION: Not required.
VENTILATION: Local exhaust.
PROTECTIVE GLOVES: Not required.
EYE PROTECTION: Not required.
1PHARMACIA Print Date: December 05, 2001
Revision Date: December 10, 1999
Agent Id#: 55188
Page: 3 of 4
**** MATERIAL SAFETY DATA SHEET ****
9. PHYSICAL AND CHEMICAL PROPERTIES
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PHA MSDS - ROGAINE(R) EXTRA STRENGTH
APPEARANCE/PHYSICAL STATE: Clear, colorless to light yellow liquid.
BOILING POINT: 78 C (172 F) (ethanol)
SPECIFIC GRAVITY (WATER=1): 0.98 - 0.991
10. STABILITY AND REACTIVITY
STABILITY: Stable.
PHYSICAL CONDITIONS TO AVOID: Fires, hot surfaces and ignition sources.
INCOMPATIBILITY WITH OTHER MATERIALS: None.
HAZARDOUS DECOMPOSITION PRODUCTS: None.
HAZARDOUS POLYMERIZATION: Does not occur.
11. TOXICOLOGICAL INFORMATION
ACUTE STUDIES:
EYE IRRITATION (RABBIT): Minimally irritating.
SKIN LD50 (RAT): > 2007 mg/kg (minoxidil).
SENSITIZATION: Tests for sensitization were negative as well as those
conducted in the guinea pig for phototoxicity and photoallergenicity.
INTRAVENOUS LD50 (RAT): 49 mg/kg (minoxidil).
INTRAVENOUS LD50 (MOUSE): 51 mg/kg (minoxidil).
ORAL LD50 (RAT): 1321 mg/kg (minoxidil); 7060 mg/kg (ethanol).
ORAL LD50 (MOUSE): 2457 mg/kg (minoxidil).
INTRAPERITONEAL LD50 (RAT): 500 mg/kg (minoxidil).
INTRAPERITONEAL LD50 (MOUSE): 1001 mg/kg (minoxidil).
SUBCUTANEOUS LD50 (RAT): 1480 mg/kg (minoxidil).
SUBCUTANEOUS LD50 (MOUSE): 3120 mg/kg (minoxidil).
OTHER STUDIES:
GENOTOXICITY: Minoxidil was not mutagenic in the Ames test, the DNA
damage/alkaline elution assay or the rat micronucleus test.
REPRODUCTION/FERTILITY: In a study in which male and female rats received one
or five times the maximum recommended human oral antihypertensive dose of
minoxidil, there was a dose-dependent reduction in conception rate. Oral
administration of minoxidil has been associated with evidence of increased
fetal resorption in rabbits, but not rats, when administered at five times
the maximum recommended oral antihypertensive human dose. There was no
evidence of teratogenic effects of orally administered minoxidil in rats or
rabbits. Subcutaneous administration of minoxidil to pregnant rats at 80
mg/kg/day (approximately 2000 times the maximal systemic human exposure
from daily topical administration) was maternally toxic, but not
teratogenic. Higher subcutaneous doses produced evidence of developmental
toxicity. Adequate and well controlled studies have not been conducted in
pregnant women treated with minoxidil; therefore the safety of exposure in
pregnant women has not been determined.
CARCINOGENICITY: No evidence for carcinogenicity was detected in rats or
rabbits when minoxidil was applied to the skin for up to one year. Dietary
administration of minoxidil to mice for up to 24 months was associated with
an increased incidence of malignant lymphomas in females and an increased
incidence of hepatic nodules in males. The lymphoma incidence was
unrelated to dose level and at all doses, was within the range seen in
control groups from other studies employing mice from the same colony. The
1PHARMACIA Print Date: December 05, 2001
Revision Date: December 10, 1999
Agent Id#: 55188
Page: 4 of 4
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incidence of hepatic nodules was dose dependent with a significant increase
observed at 63, but not at 10 or 25 mg/kg/day. There was no effect of the
drug on the incidence of malignant tumors of the liver. As with the
lymphomas, the incidence of hepatic nodules was within the historical
control range for the subject mouse colony. No evidence of carcinogenic
potential was obtained from a dietary administration study of minoxidil in
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PHA MSDS - ROGAINE(R) EXTRA STRENGTH
rats. However, the rat study involved only 1/3 the number of animals and
half the maximum dosage level evaluated in the mouse experiment, and
shorter durations of administration (up to 15 months in males and 22 months
in females).
12. DISPOSAL CONSIDERATIONS
WASTE DISPOSAL METHOD: Dispose of by incineration in accordance with applicable
international, national, state, and/or local waste disposal regulations.
13. SHIPPING REGULATIONS
TRANSPORTATION MODE: AIR, SURFACE, WATER
PROPER SHIPPING NAME: Ethyl Alcohol Solution
HAZARD CLASS: 3 (FLAMMABLE LIQUID)
SUBSIDIARY RISK: (NONE)
UN/NA NUMBER: UN1170
PACKING GROUP: III
EMERGENCY RESPONSE GUIDE: 127
IMDG CODE PAGE: 3337
TRANSPORTATION LABELS: FLAMMABLE LIQUID
SPECIAL PROVISIONS: None known.
DOT EXEMPTION FOR ETHYL ALCOHOL (DOT E-9275) APPLIES TO THE CONSUMER COMMODITY
PACKAGE FOR THIS PRODUCT.
14. OTHER INFORMATION
REVIEWED BY: Environment and Safety.
DISCLAIMER: The information contained in the MSDS is believed to be correct as
of its date of issuance. BY MAKING THE MSDS AVAILABLE, PHARMACIA & UPJOHN CO.
DOES NOT MAKE ANY EXPRESS OR IMPLIED WARRANTY (INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE) REGARDING THE MSDS, ITS
ACCURACY OR THE PRODUCT TO WHICH IT RELATES. Anyone using this information
agrees that Pharmacia & Upjohn shall not be held liable (based on its
negligence or otherwise) for any personal injury or other damage relating to,
or arising from such use, including direct, incidental, or consequential
damage and such user agrees to indemnify Pharmacia & Upjohn for any claims
arising out of its use.
15. LABELING
This drug is subject to FDA labeling requirements; therefore, it is exempt from
the labeling requirements of the OSHA Hazard Communication Standard.
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