Eczema Plus Kids Soothing Body Cream by Skinfix, Inc.

Eczema Plus Kids Soothing Body Cream by

Drug Labeling and Warnings

Eczema Plus Kids Soothing Body Cream by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECZEMA PLUS KIDS SOOTHING BODY CREAM- colloidal oatmeal cream 
Skinfix, 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%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and dermatitis.

Warnings

For external use only

When using this product

• Avoid contact with 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 right away.

Directions

Apply generously to affected areas, especially after bathing.

Other information

Store at 65-75°F. May stain fabrics.

For adults and children two years of age and older.

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl-Caprylate/Caprate, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethyhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Oil, Oryza Sativa (Rice) Bran Exract, Phenoxyethanol, Polyglyceryl-2 Stearate, Potassium Sorbate,Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Stearyl Alcohol, Tocopherol, Trisodium Ethylenediamine Disuccinate, Vitis Vinifera (Grape) Seed Oil, Water (Aqua/Eau), Xanthan Gum.

ECZEMA PLUS KIDS SOOTHING BODY CREAM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT (UNII: Z6J799EAJK)
OAT KERNEL OIL (UNII: 3UVP41R77R)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
RICE BRAN (UNII: R60QEP13IC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALMOND OIL (UNII: 66YXD4DKO9)
ROSEMARY (UNII: IJ67X351P9)
JOJOBA OIL (UNII: 724GKU717M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TOCOPHEROL (UNII: R0ZB2556P8)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-111-14	177 mg in 1 TUBE; Type 0: Not a Combination Product	11/14/2016	01/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/14/2016	01/03/2020

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020

Document Id: b0b3519e-21ed-41d7-9ea2-00545aef2870

34390-5

Set id: cf6c977c-dd6f-4d99-b9d7-0a999f1183d4

Version: 3

Effective Time: 20200103

 

Skinfix, Inc.