Eczema Plus Soothing by Skinfix, Inc.

Eczema Plus Soothing by

Drug Labeling and Warnings

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

Drug Details [pdf]

ECZEMA PLUS SOOTHING- colloidal oatmeal lotion 
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 dry, cracked skin and helps relieve minor skin irritations and itching due to eczema.

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 as needed.

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Kernel Oil, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Caprylyl-Caprylate/Caprate, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethyhexylglycerin, Glycerin, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Oil, Oryza Sativa (Rice) Bran Exract, Phenoxyethanol, Potassium Sorbate, Propanediol,  Prunus Armeniaca (Apricot) Kernel Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Olivate, Tocopherol, Trisodium Ethylenediamine Disuccinate, Water (Aqua/Eau), Xanthan Gum.

ECZEMA PLUS SOOTHING 
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-102
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT KERNEL OIL (UNII: 3UVP41R77R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL CAPRYLATE (UNII: MM00XO86JQ)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
RICE BRAN (UNII: R60QEP13IC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL (UNII: 5965N8W85T)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ROSEMARY (UNII: IJ67X351P9)
JOJOBA OIL (UNII: 724GKU717M)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TOCOPHEROL (UNII: R0ZB2556P8)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-102-28	370 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2015	01/03/2020
2	NDC: 61328-102-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2015	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: 1bd274b2-a74b-4b95-91e4-a2a04f0a6ae1

34390-5

Set id: d85830fb-7982-4887-8e4b-d4bfbfcfaa9e

Version: 5

Effective Time: 20200103

 

Skinfix, Inc.