Eczema Plus Soothing Body by Skinfix, Inc.

Eczema Plus Soothing Body by

Drug Labeling and Warnings

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

Drug Details [pdf]

ECZEMA PLUS SOOTHING BODY- 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.

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Active Ingredients

Colloidal Oatmeal 2%

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.

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.

Inactive Ingredients

allantoin, aloe barbadensis leaf juice, avena sativa (oat) extract, avena sativa kernel oil, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, caprylyl–caprylate/caprate citric acid, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) extract, moringa oil/hydrogenated moringa oil esters, oryza sativa (rice) bran extract, phenoxyethanol, polyglyceryl-2-stearate, potassium sorbate, rosmarinus officinalis (rosemary) leaf extract, simmondsia chinensis (jojoba) seed oil, stearyl alcohol, tocopherol, trisodium ethylenediamine disuccinate, vitis vinifera (grape) seed oil, water/aqua, xanthan gum.

ECZEMA PLUS SOOTHING BODY 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
OAT KERNEL OIL (UNII: 3UVP41R77R)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
RICE BRAN (UNII: R60QEP13IC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
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: 61328-103-28	236 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2017	01/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/23/2015	01/03/2020

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020

Document Id: 6b829ea2-8255-4407-88a0-396507c5931b

34390-5

Set id: 3eb7f606-9053-46c9-be79-a4f95cfc305e

Version: 7

Effective Time: 20200103

 

Skinfix, Inc.