ECZEMA HAND RELIEF- colloidal oatmeal cream

ECZEMA HAND RELIEF by

Drug Labeling and Warnings

ECZEMA HAND RELIEF by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc., SIGAN INDUSTRIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ECZEMA HAND RELIEF 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-010
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 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-010-00	90 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	10/01/2023

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Establishment
Name	Address	ID/FEI	Business Operations
SIGAN INDUSTRIES INC		255106239	manufacture(61328-010)