ISOPROPYL RUBBING ALCOHOL 50%  WITH WINTERGREEN- isopropyl alcohol liquid 
Singhfam Corporation

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.

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ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

Active ingredients (by volume)

Isopropyl alcohol (50% conc.)

Purpose

first aid antiseptic

Uses

Warnings

For external use only; flammable, keep away from fire or flame, heat, spark, electrical.

Ask a doctor before use if you have

When using this product

Stop using this product if

Keep this and all drugs out of the reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1212) immediately

Directions

Other information

Inactive Ingredients

Water(Aqua), Methyl Salicylate, FD&C Blue #1, FD&C Yellow #5

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

FIRST AID ANTISEPTIC

12 FL.OZ (355 mL)

image description

ISOPROPYL RUBBING ALCOHOL 50%   WITH WINTERGREEN
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL50 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52920-130-41118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:52920-130-42177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:52920-130-43237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:52920-130-44296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:52920-130-45354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:52920-130-46414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7NDC:52920-130-47473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/10/2015
Labeler - Singhfam Corporation (019499958)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52920-130)

Revised: 8/2015
Document Id: 1d0b5bfe-3dd0-43be-e054-00144ff8d46c
Set id: c6d5896a-56b1-41f2-9c06-e8ffcfdf7e50
Version: 1
Effective Time: 20150811
 
Singhfam Corporation