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 1.0%

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 3, 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)  
OAT (UNII: Z6J799EAJK)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
ISOCETYL ALCOHOL (UNII: 1800H64066)  
CERAMIDE 3 (UNII: 4370DF050B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-355-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/03/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/03/2012
Labeler - CVS PHARMACY (062312574)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(59779-355)

Revised: 11/2018
Document Id: ce6f9db4-9e0a-427f-9076-72fc46ba89dc
Set id: c7b1fc67-ccd1-4ea9-aed5-c148b2d7fb2a
Version: 2
Effective Time: 20181112
 
CVS PHARMACY