DERMATITIS FACE BALM- colloidal oatmeal ointment

DERMATITIS FACE BALM by

Drug Labeling and Warnings

DERMATITIS FACE BALM by is a Otc medication manufactured, distributed, or labeled by Canadian Custom Packaging Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

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, glycine soja (soybean) oil, paraffin wax, petrolatum, prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, tocopherol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMATITIS FACE BALM 
colloidal oatmeal ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54291-040
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)
SOYBEAN OIL (UNII: 241ATL177A)
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: 54291-040-01	60 g in 1 TUBE; Type 0: Not a Combination Product	12/26/2018
2	NDC: 54291-040-02	13.5 g in 1 TUBE; Type 0: Not a Combination Product	12/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/26/2018

Labeler - Canadian Custom Packaging Company (207062514)

Registrant - Canadian Custom Packaging Company (207062514)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Custom Packaging Company		207062514	manufacture(54291-040)