ECZEMA CARE- colloidal oatmeal lotion

Eczema Care by

Drug Labeling and Warnings

Eczema Care by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Colloidal Oatmeal 1%

Purpose

Skin protectant

Uses

• Temporarily protects and helps relieve minor skin itching and irritation due to eczema.

Warnings

For external use only.

When using this product

• avoid contact with eyes.
• if contact occurs, rinse thoroughly with water.

Stop using this product and ask a doctor if

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

Keep out of reach of children.

• In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• for mild to moderate eczema only, apply as needed or as directed by a physician.

Other information

• store at room temperature.

Inactive ingredients

Water (Aqua), Glycerin, Distearyldimonium Chloride, Panthenol, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Avena Sativa (Oat) Kernel Extract, Benzalkonium Chloride, Isocetyl Alcohol, Ceramide NP, Sodium Chloride.

Label copy

INGREDIENTS AND APPEARANCE

ECZEMA CARE 
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-355
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PANTHENOL (UNII: WV9CM0O67Z)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
OAT KERNEL OIL (UNII: 3UVP41R77R)
STEARETH-20 (UNII: L0Q8IK9E08)
OAT (UNII: Z6J799EAJK)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
ISOCETYL ALCOHOL (UNII: 1800H64066)
CERAMIDE NP (UNII: 4370DF050B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-355-07	216 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/28/2017

Labeler - CVS Pharmacy (062312574)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(59779-355)