AFTATE ZINC OXIDE- zinc oxide ointment 
Sabel Med 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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Zinc Oxide Ointment (1 oz and 2 oz)

Active Ingredient

Inactive ingredient

Keep out of reach

purpose

Dosage

usage

warnings

principle display

AFTATE ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70356-326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70356-326-0256 g in 1 TUBE; Type 0: Not a Combination Product05/01/2016
2NDC:70356-326-0128 g in 1 TUBE; Type 0: Not a Combination Product05/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2016
Labeler - Sabel Med LLC (091476000)

Revised: 4/2016
Document Id: 2fd39d46-98e5-42a7-e054-00144ff88e88
Set id: 2fd39d46-98e4-42a7-e054-00144ff88e88
Version: 1
Effective Time: 20160406
 
Sabel Med LLC