DIAPER RASH BALM- skin protectant ointment 
Skinfix, 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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Diaper Rash Balm

Package Label Principal Display

Treats rash, redness & Irritation

Uses - helps treat and prevent diaper rash.  protects chafed skin due to diaper rash and helps seal out wetness.

Warnings - For external use only

When using this product . Avoid contact with eyes

Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away

Directions - Change wet and soiled diapers promptly.  Cleanse the diaper area and allow to dry.  Apply balm liberally as often as necessary, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Image components

DIAPER RASH BALM 
skin protectant ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-001
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
PETROLATUM (UNII: 4T6H12BN9U)  
ALCOHOL (UNII: 3K9958V90M)  
SOYBEAN OIL (UNII: 241ATL177A)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
JOJOBA OIL (UNII: 724GKU717M)  
WHITE WAX (UNII: 7G1J5DA97F)  
PARAFFIN (UNII: I9O0E3H2ZE)  
ALLANTOIN (UNII: 344S277G0Z)  
BENZOIN RESIN (UNII: GK21SBA74R)  
LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93)  
TOLU BALSAM (UNII: TD2LE91MBE)  
ALOE (UNII: V5VD430YW9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-001-0160 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/09/2013
Labeler - Skinfix, Inc. (203158183)
Registrant - Product Integrity Laboratory, LLC (783863694)
Establishment
NameAddressID/FEIBusiness Operations
Canadian Custom Packaging Company207062514manufacture(61328-001)

Revised: 12/2013
Document Id: ceef5837-e43b-48bf-a886-41e8dc9effdc
Set id: f4dae005-89bd-4f2f-bc92-2040ed06e8ad
Version: 3
Effective Time: 20131209
 
Skinfix, Inc.