SMART CHOICE INCONTINENCE (70936-102) - DELIST

SMART CHOICE INCONTINENCE by

Drug Labeling and Warnings

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

Drug Details [pdf]

SMART CHOICE INCONTINENCE- allantoin, dimethicone cream 
SMART CHOICE MEDICAL INC.

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SMART CHOICE INCONTINENCE (70936-102) - DELIST

ACTIVE INGREDIENT:

• ALLANTOIN             1.5%
• DIMETHICONE         2%

PURPOSE:

SKIN PROTECTANT

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:

• 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 CHILDERN:

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

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. USE AS MANY TIMES A DAY AS NECESSARY

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

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, 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

SMART CHOICE INCONTINENCE 
allantoin, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70936-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1.5 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 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 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: 70936-102-11	135 g in 1 TUBE; Type 0: Not a Combination Product	08/23/2016	12/31/2023
2	NDC: 70936-102-12	270 g in 1 TUBE; Type 0: Not a Combination Product	08/23/2016	12/31/2023
3	NDC: 70936-102-22	270 g in 1 JAR; Type 0: Not a Combination Product	08/23/2016	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/23/2016	12/31/2023

Labeler - SMART CHOICE MEDICAL INC. (046383276)

Revised: 5/2024

Document Id: 1831f3c9-6db3-cb0b-e063-6294a90a5b49

34390-5

Set id: 91aae28f-9cc1-46f9-8665-3d4be9bb1fbd

Version: 11

Effective Time: 20240511