Kids Eczema Sheer Face by Skinfix, Inc.

Kids Eczema Sheer Face by

Drug Labeling and Warnings

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

Drug Details [pdf]

KIDS ECZEMA SHEER FACE- colloidal 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 3%

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.

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 to affected areas as needed.

OTHER INFORMATION

STORE AT 65-75°F. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER.

Inactive Ingredients

Allantoin, Beeswax, butyrospermum parkii (shea) butter, cocos nucifera (coconut) oil, paraffin wax, petrolatum, prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, tocopherol.

KIDS ECZEMA SHEER FACE 
colloidal oatmeal ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-108-12	55 g in 1 TUBE; Type 0: Not a Combination Product	02/27/2017	01/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/27/2017	01/03/2020

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020

Document Id: d916f424-70a4-4c22-9d86-3e93d946ca4d

34390-5

Set id: 1c8bc693-d2bb-4f20-8f53-71aaa78e2ed5

Version: 2

Effective Time: 20200103

 

Skinfix, Inc.