Active Ingredients
Active Ingredients
Salicylic Acid 1%
Blemish Spot Treatment Cream
FDA Label NDC 83657-472
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skin Script, Llc for the product Blemish Spot Treatment (NDC 83657-472). 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 ingredients, purpose, uses, questions or comments?, warnings, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
Acne Treatment
Uses
Uses
- For the treatment of acne.
- Dries and clears acne blemishes and allows skin to heal.
- Penetrates pores to reduce the number of acne blemishes, blackheads, and whiteheads.
- Helps prevent the development of new acne blemishes, blackheads, and whiteheads.
Questions Or Comments?
Questions or comments?
Skin Script™
Chandler, AZ 85226
www.skinscriptrx.com
Warnings
Warnings
For external use only
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.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away.
Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Directions
· Clean the skin thoroughly before applying this product · Cover the entire affected area
with a thin layer one to three times daily · Because excessive 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 skin care professional · If bothersome dryness or
peeling occurs, reduce application to once a day or every other day
Inactive Ingredients
Inactive Ingredients
Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Glycolic Acid, Coco-Caprylate/Caprate,
Cetearyl Alcohol, Cetearyl Glucoside, Glyceryl Stearate, Dicaprylyl Ether, Gluconolactone,
Xanthan Gum, Sodium Benzoate, Lithium Magnesium Sodium Silicate, Acetyl Tributyl Citrate,
Hamamelis Virginiana (Witch Hazel) Water, Fructooligosaccharides (D-beta), Alcohol,
Glucosamine HCl (D), Phenyl t-Butylnitrone (Spin Trap), Citric Acid, Sodium Hydroxide
Recent Major Changes
Correcting listing Uses section
* Please review the disclaimer below.
