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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:61328-001-0160 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/FEIOperations
Canadian Custom Packaging Company207062514manufacture(61328-001)

 
Skinfix, Inc.

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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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