DAILY ECZEMA REGIMEN- oatmeal kit

DAILY ECZEMA REGIMEN by

Drug Labeling and Warnings

DAILY ECZEMA REGIMEN by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

COLLOIDAL OATMEAL

PURPOSE

PURPOSE

SKIN PROTECTANT

INDICATIONS & USAGE

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATIONS AND ITCHING DUE TO ECZEMA, RASH AND DERMATITIS.

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES.

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

APPLY GENEROUSLY TO AFFECTED AREAS, ESPECIALLY AFTER BATHING.

OTHER INFORMATION

STORE AT 65-80°f. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER.

INACTIVE INGREDIENTS

ALLANTOIN, BEESWAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCINE SOYA (SOYBEAN) OIL, PARAFFIN WAX, PETROLATUM, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, TOCOPHEROL, ZINC OXIDE.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAILY ECZEMA REGIMEN 
oatmeal kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-901

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-901-93	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		1
Part 2		1
Part 3		1

Part 1 of 3

ECZEMA BALM 
oatmeal ointment

Product Information
Item Code (Source)	NDC: 61328-109
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 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
ZINC OXIDE (UNII: SOI2LOH54Z)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/22/2015

Part 2 of 3

ECZEMA PLUS SOOTHING 
colloidal oatmeal lotion

Product Information
Item Code (Source)	NDC: 61328-102
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 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT KERNEL OIL (UNII: 3UVP41R77R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
SUNFLOWER OIL (UNII: 3W1JG795YI)
RICE BRAN (UNII: R60QEP13IC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL (UNII: 5965N8W85T)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ROSEMARY (UNII: IJ67X351P9)
JOJOBA OIL (UNII: 724GKU717M)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TOCOPHEROL (UNII: R0ZB2556P8)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/23/2015

Part 3 of 3

SOOTHING WASH 
lotions, oils, powders, and creams

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
INGR	COCO GLUCOSIDE (UNII: ICS790225B)
INGR	GLYCERYL OLEATE (UNII: 4PC054V79P)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
INGR	MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)
INGR	HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
INGR	RICE BRAN (UNII: R60QEP13IC)
INGR	ROSEMARY (UNII: IJ67X351P9)
INGR	APRICOT KERNEL OIL (UNII: 54JB35T06A)
INGR	JOJOBA OIL (UNII: 724GKU717M)
INGR	AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		05/22/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/02/2015

Labeler - Skinfix, Inc. (203158183)