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70% Isopropyl Rubbing Alcohol with Wintergreen

Dosage form: liquid
Ingredients: ISOPROPYL ALCOHOL 70mL in 100mL
Labeler: AMERICAN CONSUMER PRODUCTS LLC
NDC Code: 18027-005

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.

70% Isopropyl Rubbing Alcohol with Wintergreen

Active Ingredient (by volume)

Isopropyl alcohol (70% conc.)

Purpose

Topical Antimicrobial

Uses

  • decrease germs in minor cuts and scrapes.
  • helps relieve minor muscular aches due to exertion.

Warnings

For external use only

  • flammable, keep away from fire and flame
  • will produce serious gastric disturbances if taken internally.

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

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area

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

  • apply to skin directly or with clean gauze, cotton or swab
  • for rubbing, apply liberally and rub with hands

Other information

  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • keep bottle tightly closed

Inactive Ingredients

Water (Aqua), Methyl Salicylate, Laneth-75, FD&C Blue #1, FD&C Yellow #5

PRINCIPAL DISPLAY PANEL

70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGEEN

Topical Antimicrobial

12 FL.OZ (354 mL)

70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:18027-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
METHYL SALICYLATE 
PEG-75 LANOLIN 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:18027-005-01118 mL in 1 BOTTLE, PLASTIC
2NDC:18027-005-02177 mL in 1 BOTTLE, PLASTIC
3NDC:18027-005-03237 mL in 1 BOTTLE, PLASTIC
4NDC:18027-005-04296 mL in 1 BOTTLE, PLASTIC
5NDC:18027-005-05354 mL in 1 BOTTLE, PLASTIC
6NDC:18027-005-06414 mL in 1 BOTTLE, PLASTIC
7NDC:18027-005-07473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/2017
Labeler - AMERICAN CONSUMER PRODUCTS LLC (858427334)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(18027-005)

Revised: 07/2017
 
AMERICAN CONSUMER PRODUCTS LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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