ECZEMA DERMATITIS RELIEF BALM- 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 5%

PURPOSE

Skin protectant

USES

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

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

DIRECTIONS

Apply as needed to face and body.

INACTIVE INGREDIENTS

Water/Aqua/Eau, Glycerin, Annona Cherimola Fruit Extract, Jojoba Oil/Macadamia Seed Oil Esters, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Coco-Caprylate/Caprate, Sorbitan Olivate, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Octyldodecanol, Triheptanoin, Allantoin, Zinc Oxide, Squalene, Helianthus Annuus (Sunflower) Seed Wax, Phytosteryl Macadamiate, Phytosterols, Lecithin, Acetyl Glutamine, Castanea Sativa (Chestnut) Leaf Extract, Ceramide NP, Amylopectin, Chlorophyllin-Copper Complex, Phytosphingosine, Ceramide AP, Cholesterol, Folic Acid, Hexapeptide-11, Oligopeptide-1, Oligopeptide-2, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Oligopeptide-3, Tocopherol, Lithothamnion Calcareum Extract, Ceramide EOP, Carbomer, Sodium Stearoyl Glutamate, C9-12 Alkane, Polyurethane-100, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Caprylic/Capric Triglyceride, Sodium Lauroyl Lactylate, Sodium Hydroxide, Sodium Citrate, Propanediol, Polyhydroxystearic Acid, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Citric Acid, Xanthan Gum, Lactic Acid, Sodium Carbonate, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol.

QUESTIONS?

1.866.927.2783

package label

ECZEMA DERMATITIS RELIEF BALM 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MACADAMIA SEED OIL GLYCERETH-8 ESTERS (UNII: C6734SM77O)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SHEA BUTTER (UNII: K49155WL9Y)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SQUALANE (UNII: GW89575KF9)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PROPANEDIOL (UNII: 5965N8W85T)  
CASTANEA SATIVA LEAF (UNII: IV3S2HH53G)  
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
HEXAPEPTIDE-11 (UNII: NCJ63WU6BY)  
LACTIC ACID (UNII: 33X04XA5AT)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
WATER (UNII: 059QF0KO0R)  
TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
ALLANTOIN (UNII: 344S277G0Z)  
SQUALENE (UNII: 7QWM220FJH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ACEGLUTAMIDE (UNII: 01J18G9G97)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
FOLIC ACID (UNII: 935E97BOY8)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CHERIMOYA (UNII: 33WVT714QS)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-112-2050 g in 1 BOTTLE, PUMP; 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(61328-112)

Revised: 5/2023
Document Id: fb801d20-9bed-1c71-e053-6394a90a6e95
Set id: fb801d20-9bec-1c71-e053-6394a90a6e95
Version: 1
Effective Time: 20230512
 
Skinfix, Inc.