ECZEMA INTENSIVE DAILY RELIEF BODY- colloidal oatmeal cream cream 
Skinfix, Inc.

----------

ECZEMA+ INTENSIVE DAILY RELIEF BODY CREAM

colloidal oatmeal 2%

Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema.

Skin protectant

For external use only.

When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.

If swallowed get medical help or contact a poison control center right away.

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Apply generously to affected areas.

Water/Eau/Aqua, Glycerin, Triheptanoin, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Cetyl Stearate, Caprylyl Caprylate/Caprate, Annona Cherimola Fruit Extract, Glyceryl Stearate, Jojoba Oil/Macadamia Seed Oil Esters, Stearyl Alcohol, Vegetable Oil/Huile Végétale, Helianthus Annuus (Sunflower) Seed Oil, Oryza Sativa (Rice) Bran Extract, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Helianthus Annuus (Sunflower) Extract, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Phytosteryl Macadamiate, Amylopectin, Phytosterols, Acetyl Glutamine, Lecithin, Lithothamnion Calcareum Extract, Hexapeptide-11, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Folic Acid, Oligopeptide-3, Oligopeptide-1, Oligopeptide-2, Lactic Acid, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Ceramide EOP, Xanthan Gum, Potassium Sorbate, Citric Acid, Trisodium Ethylenediamine Disuccinate, Ethylhexylglycerin, Tocopherol, Sodium Citrate, Propanediol, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Caprylyl Glycol, Sodium Lauroyl Lactylate, Sodium Benzoate, Carbomer, Phenoxyethanol.

1.866.927.2783

package label

ECZEMA INTENSIVE DAILY RELIEF BODY 
colloidal oatmeal cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
HEXAPEPTIDE-11 (UNII: NCJ63WU6BY)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)  
CERAMIDE NP (UNII: 4370DF050B)  
CETYL STEARATE (UNII: 06RI5UQA7L)  
CHERIMOYA (UNII: 33WVT714QS)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
CERAMIDE AP (UNII: F1X8L2B00J)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SQUALENE (UNII: 7QWM220FJH)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA SEED OIL GLYCERETH-8 ESTERS (UNII: C6734SM77O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ROSEMARY (UNII: IJ67X351P9)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PROPANEDIOL (UNII: 5965N8W85T)  
LACTIC ACID (UNII: 33X04XA5AT)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ACEGLUTAMIDE (UNII: 01J18G9G97)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
RICE BRAN (UNII: R60QEP13IC)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALLANTOIN (UNII: 344S277G0Z)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CORN OIL (UNII: 8470G57WFM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
JOJOBA OIL (UNII: 724GKU717M)  
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
SOY STEROL (UNII: PL360EPO9J)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FOLIC ACID (UNII: 935E97BOY8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-210-00177 g in 1 TUBE; Type 0: Not a Combination Product01/07/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01601/07/2024
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)
Establishment
NameAddressID/FEIBusiness Operations
SIGAN INDUSTRIES INC255106239manufacture(61328-210)

Revised: 1/2024
Document Id: 0e673ba3-ea94-c414-e063-6294a90ac794
Set id: 0be3c631-bc9b-00a9-e063-6394a90abcbb
Version: 2
Effective Time: 20240107
 
Skinfix, Inc.