Label: 91% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid
- NDC Code(s): 52862-028-01
- Packager: Home Smart Products
- 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 November 22, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (by volume):
- Purpose
- Uses
-
Warnings
• For external use only; flammable, keep away from fire or flame, heat, spark, electrical, etc.
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 doctor
Stop using this product if
• Condition persists or gets worse
- Directions
- Other information
- Inactive Ingredient
-
SPL UNCLASSIFIED SECTION
AS 9175
Use only in a well ventilated area
Fumes may be harmful
WARNING FLAMMABLE
keep away from fire or flame!
91% by volume
TAMPER EVIDENT: DO NOT USE IF THE UNDER CAP SAFETY FOIL IS BROKEN OR MISSING
Made in India
DISTRIBUTED:
JMD ALLSTAR IMPEX INC
120 ETHEL ROAD, PISCATAWAY,
NJ 08854, USA
DESIGNED IN THE USA
- Packaging
-
INGREDIENTS AND APPEARANCE
91% ISOPROPYL RUBBING ALCOHOL
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52862-028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 91 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:52862-028-01 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/14/2021 Labeler - Home Smart Products (161872676) Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt Ltd. 726025211 manufacture(52862-028)