Label: U 99% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 73003-007-01, 73003-007-02, 73003-007-03, 73003-007-04, view more73003-007-05, 73003-007-06, 73003-007-07 - Packager: BIOTEK INDIA
- 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 September 3, 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
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only; flammable, keep away from fire or flame, heat, spark, electrical
Ask a doctor before use if you have
• deep punctured wounds, animal bites or serious burns
When using this product
• do not get into eyes
• do not apply over large areas of the body
• do not use longer than one week unless directed by a doctorStop using this product if
• condition persists or gets worse
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
FIRST AID ANTISEPTIC
For Rubbing & Massaging
Use only in a well ventilated area;
Fumes may be harmful.
WARNINGS FLAMMABLE!
Keep away from fire or flame!
TAMPER EVIDENT: DO NOT USE IF THE UNDER CAP SAFETY FOIL IS BROKEN OR MISSING.
Made in India
Distributed by: Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817
- Packaging
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INGREDIENTS AND APPEARANCE
U 99% ISOPROPYL RUBBING ALCOHOL
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73003-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 99 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:73003-007-01 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/20/2020 2 NDC:73003-007-02 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/20/2020 3 NDC:73003-007-03 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/20/2020 4 NDC:73003-007-04 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/20/2020 5 NDC:73003-007-05 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/20/2020 6 NDC:73003-007-06 414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/20/2020 7 NDC:73003-007-07 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/20/2020 Labeler - BIOTEK INDIA (675484458) Establishment Name Address ID/FEI Business Operations BIOTEK INDIA 675484458 manufacture(73003-007)
