SMART CHOICE INCONTINENCE- allantoin, dimethicone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Available from:

SMART CHOICE MEDICAL INC.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

SMART CHOICE INCONTINENCE- ALLANTOIN, DIMETHICONE CREAM
SMART CHOICE MEDICAL INC.
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SMART CHOICE INCONTINENCE (70936-102)
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)
CETOSTEARY