ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN- isopropyl alcohol liquid 
Universal Distribution Center LLC

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)

label

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-051
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:52000-051-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
2NDC:52000-051-02177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
3NDC:52000-051-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
4NDC:52000-051-04296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
5NDC:52000-051-05355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
6NDC:52000-051-06414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
7NDC:52000-051-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/2020
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52000-051)

Revised: 5/2020
Document Id: a60d8f71-ab33-ab0c-e053-2995a90a6bae
Set id: 0b185535-b1af-4128-89ca-65b0e63cd430
Version: 1
Effective Time: 20200520
 
Universal Distribution Center LLC