ECZEMA CARE- 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 Type HUMAN OTC DRUG Item Code (Source) NDC:59779-355
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-355-12 354 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 12/03/2012
Labeler - CVS PHARMACY (062312574)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Business Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(59779-355)

Revised: 12/2012
Document Id: 8e05c8f0-97bd-4ba7-9054-bad9cdaa0f1e
Set id: c7b1fc67-ccd1-4ea9-aed5-c148b2d7fb2a
Version: 1
Effective Time: 20121203
 
CVS PHARMACY