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  5. Label Information: Smart Choice Incontinence

FDA Label for Smart Choice Incontinence

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smart Choice Incontinence Product Label

The following document was submitted to the FDA by the labeler of this product Smart Choice Medical Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



ACTIVE INGREDIENT:

  • ALLANTOIN             1.5%
  • DIMETHICONE         2%

Otc - Purpose



PURPOSE:

SKIN PROTECTANT


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

Otc - 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. USE AS 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, 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


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