Active Ingredient
sulfur 5%
Spot Defy Lotion
FDA Label NDC 49825-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bioelements, Inc. for the product Spot Defy (NDC 49825-200). 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, indications, warnings, otc - keep out of reach of children, otc - when using, otc - do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
acne treatment
Indications
clears acne pimples
Warnings
for external use only.
Otc - Keep Out Of Reach Of Children
keep out of reach of children.
Otc - When Using
when using this product 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.
when using this product apply only to areas with acne.
Otc - Do Not Use
do not use on broken skin or large areas of the skin.
Directions
clean the skin thoroughly before applying this product. cover the entire affected area with a thin layer at night. if bothersome dryness or peeling occurs, reduce application to every other night.
Inactive Ingredients
Water (Aqua, Eau), Kaolin, Cetearyl Alcohol, Glyceryl Stearate SE, Glycerin, Butylene Glycol, Bentonite, Acacia Senegal Gum, Phenoxyethanol, Niacinamide, Maltodextrin, Ethylhexylglycerin, Sodium PCA, Xanthan Gum, Tocopheryl Acetate, Syringa Vulgaris (Lilac) Extract, Quartz, Dipotossium Glycyrrhizate, Centella Asiatica Extract, Hibiscus Rosa-Sinensis Flower Extract, Lavandula Angustifolia (Lavender) Extract, Origanum Vulgare Leaf Extract, Thymus Vulgaris (Thyme) Extract
Questions?
call 1.800.433.6650 monday - friday 7:30am - 4:30 pm mst
Principal Display Panel – 15 Ml Carton Label
bioelements
spot defy™
5% sulfur overnight spot treatment
to clear active acne blemishes
ACNE ACTIVIST
15 mL / .5 fl oz
Principal Display Panel – 15 mL Carton Label (Bio0i 0001 01)
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