Otc - Active Ingredient
Salicylic Acid 2%
Vanibiss Butt And Thighs
FDA Label NDC 81890-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vanibiss Inc for the product Vanibiss Butt And Thighs (NDC 81890-002). 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 otc - active ingredient, otc - purpose, use:, warnings, otc - stop use, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Acne treatment
Use:
For the treatment of acne.
Warnings
For external use only.
Do not use on children under 12 years of age unless directed by a doctor.
Otc - Stop Use
Stop use and consult a doctor if
Condition worsens or does not improve with regular use of this product as directed.
Otc - When Using
Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Clean the skin thoroughly before applying product.
Cover the entire affected area with a thin layer one to three times daily.
Because excess drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Other Safety Information
See on the top of the tube for lot number and expiration date.
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Beeswax, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cetyl Alcohol, Organic Butyrospermum Parkii (Shea) Butter, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Dimethicone, Dimethicone Crosspolymer, Polyglyceryl-6 Palmitate/Succinate, Cetearyl Alcohol, Aloe Barbadensis (Aloe Vera) Leaf Juice, Fragrance (Parfum), Sodium Hydroxide, Xanthan Gum, Disodium EDTA, Rosmarinus Officinalis (Rosemary) Extract, Tocopheryl Acetate, Mentha Piperita (Peppermint) Oil, Salix Alba Bark Extract, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hexyl Cinnamal, D-Limonene, Linalool, Benzyl Salicylate, Benzyl Alcohol, Citral.
Otc - Questions
Call (1-800-931-0171)
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