FACE VALUES EXZEMA MOISTURIZING LOTION

FACE VALUES EXZEMA MOISTURIZING LOTION

Drug Labeling and Warnings

Drug Details

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ECZEMA MOISTURIZING- colloidal oatmeal lotion 
Harmon Stores Inc.

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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FACE VALUES EXZEMA MOISTURIZING LOTION

Active Ingredients

Colloidal Oatmeal 1.0%

Purpose

Skin Protectant

Uses

Temporarily protects and helps minor skin irritation and itching due to:  eczema  rashes

Warnings

For external use only

When using this product  do not get into eyes

Stop use and ask a doctor if  condition worsens  symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Apply as needed.

Other information

  • for use on mild to moderate eczema or as directed by a physician 
  • store at room temperature.

Inactive Ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, dimethicone, panthenol, avena sativa (oat) kernel oil, steareth-20, avena sativa (oat) kernel extract, methylparaben, propylparaben, ceramide NP, sodium chloride.

FACE VALUES EXZEMA MOISTURIZING LOTION

7.3 OZ (207g)

NDC: 63940-050-86

Label

ECZEMA MOISTURIZING 
colloidal oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63940-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PANTHENOL (UNII: WV9CM0O67Z)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
STEARETH-20 (UNII: L0Q8IK9E08)  
OAT (UNII: Z6J799EAJK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CERAMIDE NP (UNII: 4370DF050B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63940-050-86207 g in 1 TUBE; Type 0: Not a Combination Product05/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/09/2017
Labeler - Harmon Stores Inc. (804085293)
Registrant - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of the Earth, Inc.008193513manufacture(63940-050)

Revised: 3/2020
 
Harmon Stores Inc.


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