Active Ingredient

Colloidal Oatmeal 1%...............................Skin Protectant

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

rashes
eczema

Warnings

For external use only

When using this product

do not get into eyes

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 as needed

Inactive ingredients

Water/Aqua/Eau, Glyverin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Glyceryl Stearate Citrate, Aloe Babadensis Leaf Juice, Cetyl Alcohol, Propanediol, Tocopheryl Acetate, Sodium Benzoate, Potassium Sorbate, Sodium Gluconate, Citric Acid, Phenoxyethanol, Biosaccharide Gum-A

Eczema Relief Cream

ECZEMA RELIEF CREAM
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71521-025
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM GLUCONATE (UNII: R6Q3791S76)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CETYL ALCOHOL (UNII: 936JST6JCN)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
PROPANEDIOL (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71521-025-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/31/2021
2	NDC:71521-025-15	15 g in 1 TUBE; Type 0: Not a Combination Product	03/17/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	03/31/2021

Labeler - Lavior Pharma Inc (080685327)