ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN- isopropyl alcohol liquid 
FOUR SEASONS TRADING INC

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 Oil

Active Ingredients (by volume)

Isopropyl alcohol (50% 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 Ingredients

Water, Methyl Salicylate, Laneth-75, FD&C Blue #1, FD&C Yellow #5.

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

TOPICAL ANTIMICROBIAL

12 FL.OZ (354 mL)

label

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69274-002
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)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69274-002-01118 mL in 1 BOTTLE, PLASTIC
2NDC:69274-002-02177 mL in 1 BOTTLE, PLASTIC
3NDC:69274-002-03237 mL in 1 BOTTLE, PLASTIC
4NDC:69274-002-04296 mL in 1 BOTTLE, PLASTIC
5NDC:69274-002-05354 mL in 1 BOTTLE, PLASTIC
6NDC:69274-002-06414 mL in 1 BOTTLE, PLASTIC
7NDC:69274-002-07473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/25/2014
Labeler - FOUR SEASONS TRADING INC (169331464)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(69274-002)

Revised: 11/2014
Document Id: 08b28434-5da3-54b9-e054-00144ff88e88
Set id: ddce0b1f-3b30-4a38-aced-6765a16831d0
Version: 1
Effective Time: 20141125
 
FOUR SEASONS TRADING INC