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.

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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 label

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)  
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:59779-355-05142 mL in 1 TUBE; Type 0: Not a Combination Product01/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/30/2019
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: 2/2019
Document Id: de5e3fad-eb01-4804-9e36-c52b32e4d850
Set id: 0e433bbc-dbf9-4393-826c-4a91a8b8e138
Version: 1
Effective Time: 20190201
 
CVS Pharmacy