Avance Aloe Incontinence Care Cream
FDA Label NDC 70936-130

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Smart Choice Medical Inc. for the product Avance Aloe Incontinence Care (NDC 70936-130). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient:, purpose, uses, warnings:, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

DIMETHICONE 5% (W/W)

Purpose

SKIN PROTECTANT

Uses

■ helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin and lips
■ helps prevent and protect from the drying effects of wind and cold weather

Warnings:

  • FOR EXTERNAL ONLY

    • DO NOT USE:

    • ON WILD OR DOMESTIC ANIMAL BITES. IF YOU HAVE AN ANIMAL BITE, CONSULT YOUR PHYSICIAN IMMEDIATELY.
    • ON INFECTIONS
    • FOR MORE THAN 10 DAYS. IF INFECTION WORSENS OR PERSISTS, SEE YOUR PHYSICIAN.

      • WHEN USING THIS PRODUCT:

      • DO NOT GET INTO EYES

        • STOP USE AND ASK A DOCTOR IF:

        • ​CONDITION WORSENS
        • SYMPTONS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW 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

Directions

  • APPPLY CREAM TO AFFECTED AREA. RUB IN GENTLY.

Inactive Ingredients

Water, Helianthus Annuus Seed Oil, Cetearyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Butylene Glycol, Urea, Zinc PCA, Aloe Barbadensis Leaf Juice, Allantoin, Panthenol, Arginine, Niacinamide, Butyrospermum
Parkii (Shea) Butter, Tocopheryl Acetate, Polysorbate 60, Salvia Officinalis (Sage) Leaf Extract, Equisetum Arvense Extract, Citrus Limon (Lemon) Fruit Extract, Acacia Senegal Gum, Xanthan Gum, Citric Acid, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate.

Package Label.Principal Display Panel

* Please review the disclaimer below.