SMART CHOICE BARRIER- allantoin, dimethicone, menthol cream

SMART CHOICE BARRIER by

Drug Labeling and Warnings

SMART CHOICE BARRIER by is a Otc medication manufactured, distributed, or labeled by SMART CHOICE MEDICAL INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT:

• ALLANTOIN              0.5%
• DIMETHICONE         2%
• MENTHOL                0.45%

PURPOSE

PURPOSE:

SKIN PROTECTANT, TOPICAL ANALGESIC

INDICATIONS & USAGE

USES

• HELPS TREAT AND PREVENT DIAPER RASH. PROTECTS CHAFED SKIN/MINOR SKIN IRRITATION
• DUE TO/ASSOCATED WITH DIAPER RASH
• HELPS PROTECTS FROM/SEAL OUT WETNESS
• TEMPORARLY PROTECTS AND HELPS RELEIVE CHAFED, CHAPPED, OR CRACKED SKIN

WARNINGS

WARNINGS:

• FOR EXTERNAL ONLY

DO NOT USE:

• ON DEEP PUNCTURE WOUNDS
• ON INFECTIONS
• ON LACERATIONS

WHEN USING THIS PRODUCT:

• AVOID CONTACT WITH EYES

STOP USE AND ASK A DOCTOR IF:

• CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDERN:

• IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

DOSAGE & ADMINISTRATION

DIRECTIONS:

GENTLY CLEAN THE IRRITATED AREA BEFORE USE. THEN APPLY A GENEROUS LAYER OF CREAM.

IT CAN BE LEFT ON THICK OR RUBBED INTO SKIN. USEAS MANY TIMES A DAY AS NECESSARY

UNTIL HEALED. FOR CONTINUOUS PROTECTION AND HEALTHY SKIN USE DAILY.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, BUTYROSPERMUN PARKII (SHEA BUTTER), GLYCERIN,

BEESWAX, CETEARYL ALCOHOL, CARTHAMUS TINDORIUS (SAFFLOWER) SEED OIL, POLYSORBATE 60,

MAGNESIUM ALUMINUM SILICATE, CALAMINE, ZINC PCA, AVENA SATIVA (OAT) KERNEL FLOUR, SODIUM PCA,

PANTHENOL (VITAMIN B5), TOCOPHERYL ACETATE (VITAMIN E), SODIUM HYALURONATE, GLYCERYL STEARATE,

SOBIC ACID, SODIUM PHYTATE, XANTHAN GUM, PHENOXYETHANOL, ETHYHEXYLGLYCERIN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SMART CHOICE BARRIER 
allantoin, dimethicone, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70936-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	.5 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.45 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
WHITE WAX (UNII: 7G1J5DA97F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ZINC OXIDE (UNII: SOI2LOH54Z)
ZINC PIDOLATE (UNII: C32PQ86DH4)
OATMEAL (UNII: 8PI54V663Y)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SORBIC ACID (UNII: X045WJ989B)
PHYTATE SODIUM (UNII: 88496G1ERL)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70936-101-11	135 g in 1 TUBE; Type 0: Not a Combination Product	08/22/2016
2	NDC: 70936-101-12	270 g in 1 TUBE; Type 0: Not a Combination Product	08/22/2016
3	NDC: 70936-101-22	270 g in 1 JAR; Type 0: Not a Combination Product	08/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/22/2016

Labeler - SMART CHOICE MEDICAL INC. (046383276)

Registrant - SMART CHOICE MEDICAL INC. (046383276)