Eczema Balm by Skinfix, Inc.

Eczema Balm by

Drug Labeling and Warnings

Eczema Balm by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECZEMA BALM- oatmeal 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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEANUT OIL (UNII: O88E196QRF)
SOYBEAN OIL (UNII: 241ATL177A)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-115-12	60 g in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2015	01/03/2020
2	NDC: 61328-115-05	5 g in 1 POUCH; Type 0: Not a Combination Product	03/15/2017	01/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/23/2015	01/03/2020

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020

Document Id: dcf11613-612d-4fc4-a58b-d1038443da9b

34390-5

Set id: b9389d83-e62e-4ad5-97b6-ab9622c156f8

Version: 2

Effective Time: 20200103

 

Skinfix, Inc.