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Diaper Rash Balm by Skinfix, Inc.

Medically reviewed on December 11, 2017

Dosage form: ointment
Ingredients: ZINC OXIDE 0.2g in 1g
Labeler: Skinfix, Inc.
NDC Code: 61328-001

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.

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.

DIAPER RASH BALM 
skin protectant ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
ALCOHOL 
SOYBEAN OIL 
SUNFLOWER OIL 
JOJOBA OIL 
WHITE WAX 
PARAFFIN 
ALLANTOIN 
BENZOIN RESIN 
LIQUIDAMBAR ORIENTALIS RESIN 
TOLU BALSAM 
ALOE 
Packaging
#Item CodePackage Description
1NDC:61328-001-02114 g in 1 JAR
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/FEIOperations
Canadian Custom Packaging Company207062514manufacture(61328-001)

 
Skinfix, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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