91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN- isopropyl alcohol liquid 
New Pride Corp

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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91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN

Active ingredient (by volume)

Isopropyl alcohol (70% concentrate)

Purpose

topical antimicrobial

Uses

Warnings

For external use only

Ask a doctor before use if you have deep puncture wounds or serious burns

When using this product

Stop use and ask a doctor if condition persists or gets worse

Keep out of reach of children.

In case of an accidental ingestion, contact a Poison Control Center immediately

Directions

Other information

Inactive ingredient

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

PRINCIPAL DISPLAY PANEL

Label

91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58037-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL91 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:58037-007-01355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/11/2020
Labeler - New Pride Corp (884264198)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(58037-007)

Revised: 1/2023
Document Id: f15a23ba-0b05-8969-e053-2a95a90a84d7
Set id: f15a6843-78bd-223c-e053-2a95a90a2033
Version: 1
Effective Time: 20230103
 
New Pride Corp