Label: BIOMAX USA- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77369-899-01, 77369-899-16 - Packager: Biomax Cosmetics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- USES
- INACTIVE INGREDIENT
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WARNINGS
For external use only. If taken internally serious gastric disturbances will result.
Flammable - keep away from heat, spark, electrical, fire or flame. Ask a doctor before use for deep or puncture wounds, animal bites or serious burns.
WHEN USING THIS PRODUCT:
• Do not get into eyes.
• Do not inhale.
• Do not apply over large areas of the body.
• Do not use longer than 1 week.
- DIRECTIONS
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SPL UNCLASSIFIED SECTION
HEALTHCARE
ISOPROPYL RUBBING ALCOHOL 70%
WARNING: FLAMMABLE,
KEEP AWAY FROM FIRE OR FLAME
ANTISEPTIC
• Topical antiseptic and sanitizer
• Antibacterial Cleansing Agent
CAUTION: Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.
Biomax Cosmetics Inc.
Houston, TX 77061
www.biomaxcosmetics.com
MADE IN USA
- Packaging
-
INGREDIENTS AND APPEARANCE
BIOMAX USA
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77369-899 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77369-899-16 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2020 2 NDC:77369-899-01 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/05/2020 Labeler - Biomax Cosmetics (084032031) Establishment Name Address ID/FEI Business Operations Biomax Cosmetics 084032031 manufacture(77369-899)
