DERMATITIS FACE BALM- 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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SKINFIX - DERMATITIS FACE BALM (61328-121)

Active Ingredients

Colloidal Oatmeal 5%

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

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

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

61328-121-1261328-121-12

DERMATITIS FACE BALM 
colloidal oatmeal ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
SOYBEAN OIL (UNII: 241ATL177A)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
ALMOND OIL (UNII: 66YXD4DKO9)  
JOJOBA OIL (UNII: 724GKU717M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-121-1213.5 g in 1 TUBE; Type 0: Not a Combination Product02/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/03/2022
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)
Establishment
NameAddressID/FEIBusiness Operations
Canadian Custom Packaging Company207062514manufacture(61328-121)

Revised: 2/2022
Document Id: 060105d3-505b-4b16-8f2e-747523bbf7f6
Set id: 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6
Version: 5
Effective Time: 20220203
 
Skinfix, Inc.