Baby Gentle Eczema Plus Soothing Body by Skinfix, Inc.

Baby Gentle Eczema Plus Soothing Body by

Drug Labeling and Warnings

Baby Gentle 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]

BABY GENTLE 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 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.

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 65-80o F. May stain fabrics.

Inactive Ingredients

allantoin, aloe barbadensis leaf juice, avena sativa (oat) extract, avena sativa (oat) kernel oil, caprylic/capric triglyceride, caprylyl caprylate/caprate citric acid, cocos nucifera (coconut) oil, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) extract, helianthus annuus (sunflower) seed oil, 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.

BABY GENTLE ECZEMA PLUS SOOTHING BODY 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
SUNFLOWER OIL (UNII: 3W1JG795YI)
RICE BRAN (UNII: R60QEP13IC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 STEARATE (UNII: VLC3W3U1PE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
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: 61328-113-12	177 mg in 1 TUBE; Type 0: Not a Combination Product	02/27/2017	01/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/27/2017	01/03/2020

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Revised: 1/2020

Document Id: 10e1f656-2d74-45d6-8c9a-66d85ff651d0

34390-5

Set id: b1a10e8d-3312-4578-8874-cc4b906259c4

Version: 2

Effective Time: 20200103

 

Skinfix, Inc.