50% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid 
AMERICAN CONSUMER PRODUCTS 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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50% Isopropyl Rubbing Alcohol

Active Ingredient (by volume)

Isopropyl alcohol (50% conc.)

Purpose

Topical Antimicrobial

Uses

Warnings

For external use only

Ask a doctor before use if you have deep puncture wounds 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 (Aqua)

PRINCIPAL DISPLAY PANEL

50% ISOPROPYL RUBBING ALCOHOL

Topical Antimicrobial

12 FL.OZ (354 mL)

label

50% ISOPROPYL RUBBING ALCOHOL 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:18027-002
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:18027-002-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
2NDC:18027-002-02177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
3NDC:18027-002-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
4NDC:18027-002-04296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
5NDC:18027-002-05354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
6NDC:18027-002-06414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
7NDC:18027-002-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
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/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(18027-002)

Revised: 7/2017
Document Id: 54c3a2d6-5dfc-2d7b-e054-00144ff88e88
Set id: 416798cb-697a-42cf-8a7c-3d17aebfe228
Version: 1
Effective Time: 20170720
 
AMERICAN CONSUMER PRODUCTS LLC