NDC | 52000-030-01, 52000-030-02, 52000-030-03, 52000-030-04, 52000-030-05, 52000-030-06, 52000-030-07 |
Set ID | a6d082ac-47b1-4847-b075-630892071885 |
Category | HUMAN OTC DRUG LABEL |
Packager | Universal Distribution Center LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
- 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.
WARNING 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
-
INGREDIENTS AND APPEARANCE
ISOPROPYL RUBBING ALCOHOL 99%
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-030 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:52000-030-01 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/04/2016 2 NDC:52000-030-02 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/04/2016 3 NDC:52000-030-03 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/04/2016 4 NDC:52000-030-04 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/04/2016 5 NDC:52000-030-05 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/04/2016 6 NDC:52000-030-06 414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/04/2016 7 NDC:52000-030-07 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/04/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/04/2016 Labeler - Universal Distribution Center LLC (019180459) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-030) Establishment Name Address ID/FEI Business Operations NOWREZ & ISMAIL SHUKRI COMPANY 534665497 manufacture(52000-030)