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GENTLE ECZEMA BALM by Skinfix, Inc.

Medically reviewed on September 27, 2016

Dosage form: ointment
Ingredients: OATMEAL 2g in 100g
Labeler: Skinfix, Inc.
NDC Code: 61328-104

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.

ACTIVE INGREDIENTS

COLLOIDAL OINTMENT 2%

PURPOSE

SKIN PROTECTANT

USES

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATIONS AND ITCHING DUE TO

  • ECZEMA
  • RASH
  • DERMATITIS.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES.

STOP USE AND ASK A DOCTOR IF

  • CONDITION WORSENS
  • SYMPTOMS LAST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

APPLY BALM LIBERALLY AS NEEDED, ESPECIALLY AFTER BATHING.

OTHER INFORMATION

STORE AT 65-80°f. MAY STAIN FABRICS.

INACTIVE INGREDIENTS

ALLANTOIN, BEESWAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PARAFFIN WAX, PETROLATUM, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, TOCOPHEROL, ZINC OXIDE.

GENTLE ECZEMA BALM 
colloidal oatmeal ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-104
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (OATMEAL) OATMEAL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
YELLOW WAX 
SHEA BUTTER 
SOYBEAN OIL 
PARAFFIN 
PETROLATUM 
ALMOND OIL 
JOJOBA OIL 
TOCOPHEROL 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:61328-104-1260 g in 1 TUBE
2NDC:61328-104-14120 g in 1 TUBE
3NDC:61328-104-977 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/09/2013
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)

 
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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