ECZEMA CARE- colloidal oatmeal lotion 
CVS Pharmacy

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.

----------

Drug Facts

Active ingredient

Colloidal Oatmeal 1%

Purpose

Skin protectant

Uses

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

Other information

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

Image of the description

ECZEMA CARE 
colloidal oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-355
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-355-07216 mL in 1 TUBE; Type 0: Not a Combination Product08/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/28/2017
Labeler - CVS Pharmacy (062312574)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(59779-355)

Revised: 9/2017
Document Id: f5fa36cb-a274-487e-8e19-6fa3119fd761
Set id: b7e688a3-0f74-4134-a1c5-68a8575e62c8
Version: 1
Effective Time: 20170905
 
CVS Pharmacy