ECZEMA MOISTURIZING: Package Insert and Label Information

ECZEMA MOISTURIZING- 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.

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

LabelLabel
ECZEMA MOISTURIZING
colloidal oatmeal lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-050
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (OATMEAL) OATMEAL 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
DISTEARYLDIMONIUM CHLORIDE
PETROLATUM
ISOPROPYL PALMITATE
CETYL ALCOHOL
DIMETHICONE
PANTHENOL
OAT KERNEL OIL
STEARETH-20
OAT
METHYLPARABEN
PROPYLPARABEN
CERAMIDE NP
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63940-050-86 207 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 05/09/2017
Labeler — Harmon Stores Inc. (804085293)
Registrant — Fruit of the Earth, Inc. (079559467)
Establishment
Name Address ID/FEI Operations
Fruit of the Earth, Inc. 008193513 manufacture (63940-050)

Revised: 03/2020 Harmon Stores Inc.

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