WALGREENS BABY ECZEMA- colloidal oatmeal cream 
Walgreen Company

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, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Panthenol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Avena Sativa (Oat) Kernel Extract, Benzalkonium Chloride, Isocetyl Alcohol, Ceramide NP, Sodium Chloride.

Questions or comments?

1-800-925-4733

Label Copy

Image of the label

WALGREENS BABY ECZEMA 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3550
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
PETROLATUM (UNII: 4T6H12BN9U)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PANTHENOL (UNII: WV9CM0O67Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
OAT (UNII: Z6J799EAJK)  
STEARETH-20 (UNII: L0Q8IK9E08)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
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:0363-3550-05142 g in 1 TUBE; Type 0: Not a Combination Product11/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/28/2017
Labeler - Walgreen Company (008965063)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(0363-3550)

Revised: 11/2017
Document Id: 7e98794d-170f-400a-acb7-8c9ab35c8e77
Set id: 4138eb24-bef2-49df-ad9c-ab6c5d381baa
Version: 1
Effective Time: 20171129
 
Walgreen Company