ECZEMA HAND RELIEF- 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 INGREDIENT

Colloidal Oatmeal 1%

USES

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

PURPOSE

Skin protectant

WARNINGS

For external use only.

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

KEEP OUT OF REACH OF CHILDREN

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

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

DIRECTIONS

Apply as needed to hands.

INACTIVE INGREDIENTS

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

QUESTIONS?

1.866.927.2783

package label

ECZEMA HAND RELIEF 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)  
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
RICE GERM (UNII: 7N2B70SFEZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCONUT OIL (UNII: Q9L0O73W7L)  
JOJOBA OIL (UNII: 724GKU717M)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
MACADAMIA SEED OIL GLYCERETH-8 ESTERS (UNII: C6734SM77O)  
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
ACEGLUTAMIDE (UNII: 01J18G9G97)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
LACTIC ACID (UNII: 33X04XA5AT)  
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
WATER (UNII: 059QF0KO0R)  
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
HEXAPEPTIDE-11 (UNII: NCJ63WU6BY)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CHERIMOYA (UNII: 33WVT714QS)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
ALLANTOIN (UNII: 344S277G0Z)  
ROSEMARY (UNII: IJ67X351P9)  
PROPANEDIOL (UNII: 5965N8W85T)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
FOLIC ACID (UNII: 935E97BOY8)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SQUALENE (UNII: 7QWM220FJH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-010-0090 g in 1 TUBE; Type 0: Not a Combination Product10/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01610/01/2023
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)
Establishment
NameAddressID/FEIBusiness Operations
SIGAN INDUSTRIES INC255106239manufacture(61328-010)

Revised: 8/2023
Document Id: 0389bab7-04fc-7cfc-e063-6394a90a22d8
Set id: 0389bab7-04fb-7cfc-e063-6394a90a22d8
Version: 1
Effective Time: 20230822
 
Skinfix, Inc.