CVS HEALTH ECZEMA SKIN RELIEF SKIN PROTECTANT- oatmeal lotion

CVS Health Eczema Skin Relief by

Drug Labeling and Warnings

CVS Health Eczema Skin Relief by is a Otc medication manufactured, distributed, or labeled by CVS Health, Garcoa Inc., Sigan Industries Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Colloidal oatmeal 2.0%

Purpose

Skin protectant

Uses

temporarily protects and helps relieve minor skin irritation and itching due to

• ⬥ eczema
• ⬥ rashes

Warnings

For external use only

When using this product avoid contact with 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 or as directed by a doctor

Other information

store at room temperature

Inactive ingredients

water, glycerin, glyceryl stearate, cetearyl alcohol, ceteareth-20, propanediol, dimethicone, cetyl alcohol, hydrolyzed jojoba esters, petrolatum, tetrasodiun EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 60, aloe barbadensis leaf juice, avena sativa (oat) kernel extract, butyrospermum parkii (shea) butter extract, zingiber officinale (ginger) root extract, C12-15 alkyl benzoate, panthenol, ceramide NP, tocopheryl acetate, magnesium ascorbyl phosphate, bisabolol, citric acid, benzyl alcohol, ethylhexylglycerin.

SPL UNCLASSIFIED SECTION

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 396 g Bottle Label

CVS
Health™

Compare to
Gold Bond®
Ultimate Eczema
Relief Lotion*

Eczema
Skin Relief
Lotion

2% COLLOIDAL OATMEAL
SKIN PROTECTANT LOTION

• Helps relieve symptoms of eczema
• Helps to relieve itching, dryness
  & irritation due to eczema
• Steroid & fragrance free
• Dermatologist tested
• Paraben & phthalate free

with Natural
Colloidal Oatmeal

NET WT 14 OZ (396 g)

05-3627

INGREDIENTS AND APPEARANCE

CVS HEALTH ECZEMA SKIN RELIEF   SKIN PROTECTANT
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-962
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y)	Oatmeal	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Propanediol (UNII: 5965N8W85T)
Dimethicone (UNII: 92RU3N3Y1O)
Cetyl Alcohol (UNII: 936JST6JCN)
Hydrolyzed Jojoba Esters (Acid Form) (UNII: UDR641JW8W)
Petrolatum (UNII: 4T6H12BN9U)
Edetate Sodium (UNII: MP1J8420LU)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
Isohexadecane (UNII: 918X1OUF1E)
Polysorbate 60 (UNII: CAL22UVI4M)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Oat (UNII: Z6J799EAJK)
Shea Butter (UNII: K49155WL9Y)
Ginger (UNII: C5529G5JPQ)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Panthenol (UNII: WV9CM0O67Z)
Ceramide NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)
Levomenol (UNII: 24WE03BX2T)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-962-01	396 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/03/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/03/2018

Labeler - CVS Health (062312574)

Registrant - Garcoa Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries Inc.		255106239	MANUFACTURE(69842-962)