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Drug Facts
Distributed by:
D3 Development, Inc., Portland, ME 04101
Made in the USA
Salicylic Acid Soap
FDA Label NDC 71819-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by D3 Development, Inc. for the product Salicylic Acid (NDC 71819-003). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Salicylic acid 2%
Otc - Purpose
Purpose
Acne treatment
Indications & Usage
Uses
- For the treatment of acne
- Reduces the number of acne pimples and allows skin to heal
- Penetrates pores to clear most acne blemishes
- Dries up acne pimples
- Helps keep skin clear of new acne blemishes, acne pimples, whiteheads, and blackheads
Warnings
Warnings
For external use only
Otc - When Using
When using this product, skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne, avoiding contact with eyes.
- Rinse thoroughly and pat dry with a clean towel
- Because bothersome dryness of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
Storage And Handling
Other information
- Store at room temperature
- Lot number and expiration date are printed on back panel.
Inactive Ingredient
Inactive ingredients
Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, titanium dioxide, table salt, olive oil, Avena Sativa (oat) kernel flour, pentasodium pentetate, tocopheryl acetate (vitamin E)
Otc - Questions
Questions?
1-800-827-3730
www.dermaharmony.com
Package Label.Principal Display Panel
dermaharmony
Salicylic Acid SOAP
For Acne, Whiteheads, & Blackheads
NET WT 4.0 OZ (113 G)
* Please review the disclaimer below.
