BABY GENTLE ECZEMA SHEER FACE- colloidal oatmeal ointment

Baby Gentle Eczema Sheer Face by

Drug Labeling and Warnings

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

Drug Details [pdf]

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. 

Inactive Ingredients

Allantoin, Beeswax, Helianthus Annuus (Sunflower) Oil, paraffin, petrolatum, simmondsia chinensis (jojoba) seed oil, tocopherol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY GENTLE ECZEMA SHEER FACE 
colloidal oatmeal ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-114-12	55 g in 1 TUBE; Type 0: Not a Combination Product	02/27/2017

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

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)