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Eczema Balm

Dosage form: ointment
Ingredients: OATMEAL 2g in 100g
Labeler: Skinfix, Inc.
NDC Code: 61328-115

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 Oatmeal 2%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and 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 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 a Poison Control Center right away.

Directions

Apply as needed.

Other Information

Store at 65-80°F. May stain fabrics. For adults and children two years of age and older.

Inactive Ingredients

Allantoin, Beeswax, Butyrospermum Parkii (Shea) Butter, Glycine Soja (Soybean) Oil, Paraffin Wax, Petrolatum, Prunus Amygdalus (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Zinc Oxide.

ECZEMA BALM 
oatmeal ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-115
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 
SHEANUT OIL 
SOYBEAN OIL 
PARAFFIN 
PETROLATUM 
ALMOND OIL 
JOJOBA OIL 
TOCOPHEROL 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:61328-115-1260 g in 1 BOTTLE
2NDC:61328-115-055 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/23/2015
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)

Revised: 03/2017
 
Skinfix, Inc.

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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