ECZEMA INTENSIVE DAILY RELIEF BODY- colloidal oatmeal cream cream

ECZEMA INTENSIVE DAILY RELIEF BODY by

Drug Labeling and Warnings

ECZEMA INTENSIVE DAILY RELIEF BODY 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 2%

INDICATIONS & USAGE

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

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

DOSAGE & ADMINISTRATION

Apply generously to affected areas.

INACTIVE INGREDIENT

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.

QUESTIONS

1.866.927.2783

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ECZEMA INTENSIVE DAILY RELIEF BODY 
colloidal oatmeal cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-210-00	177 g in 1 TUBE; Type 0: Not a Combination Product	01/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/07/2024

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Establishment
Name	Address	ID/FEI	Business Operations
SIGAN INDUSTRIES INC		255106239	manufacture(61328-210)