AVANCE CURE MOISTURIZING INCONTINENCE CREAM- allantoin, dimethicone cream

Avance Cure Moisturizing Incontinence Cream by

Drug Labeling and Warnings

Avance Cure Moisturizing Incontinence Cream 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:

Allantoin 1.5%
Dimethicone 2%

PURPOSE:

SKIN PROTECTANT

USES

Assists in the treatment of skin rash, usually caused by absorbency product and urine acidity.
Provides moisture to assist in treatment of chafed, chapped, or cracked skin.
Protects the skin from breakdown and dryness.

WARNINGS:

For external use only

Do not use:
On Deep Open Wounds
On Infections
On Skin 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 children:
If swallowed or ingested, seek medical attention or contact the Poison Control Center immediately.

DIRECTIONS:

Prepare the affected area by gently cleaning the skin surface before use. Apply a proper amount of cream to affected area. Spread the cream across the affected area by gently rubbing on the irritated skin. Repeat the process as needed, or daily to ensure constant protection until the skin is healed.

QUESTIONS?

Call 1-800-768-3801 or visit smartchoicemedical.com

INACTIVE INGREDIENTS:

Water, Butyrospermum Parkii Extract (Shea Butter), Aloe barbadensis (Aloe Vera), Maltodextrin, Glycerin, Glyceryl stearate, Bee Wax, Safflower oil, Pyrrolidone Carboxylic Acid-Na, Cetearyl alcohol, Sodium Polyglutamate, 1,3- Butylene Glycol, Panthenol, Tocopheryl Acetate, Xanthan gum, Ethylhexylglycerin, Phenoxyethanol, Ceteareth - 20, Sodium hyaluronate, Glyceryl glucoside, Avena Sativa (Oat) Protein Extract, Lactobacillus/Soymilk Ferment Filtrate, Bacillus/Soybean Ferment Extract, Propanediol, 1,2-Hexanediol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVANCE CURE MOISTURIZING INCONTINENCE CREAM 
allantoin, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70936-108
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
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
YELLOW WAX (UNII: 2ZA36H0S2V)
SAFFLOWER OIL (UNII: 65UEH262IS)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.BETA.-D-GLUCOPYRANOSE (UNII: J4R00M814D)
OAT (UNII: Z6J799EAJK)
SOYBEAN (UNII: L7HT8F1ZOD)
PROPANEDIOL (UNII: 5965N8W85T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70936-108-11	135 g in 1 TUBE; Type 0: Not a Combination Product	07/02/2018
2	NDC: 70936-108-12	270 g in 1 TUBE; Type 0: Not a Combination Product	07/02/2018
3	NDC: 70936-108-22	270 g in 1 JAR; Type 0: Not a Combination Product	07/02/2018

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)