Otc - Active Ingredient
Active Ingredients Purpose
Salicylic Acid 2%.................................................... Acne Treatment
Label (2)
Acropass Acne Cure
FDA Label NDC 71134-241
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raphas Co., Ltd for the product Acropass Acne Cure (NDC 71134-241). 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, warnings, otc - when using, otc - stop use, otc - ask doctor, otc - keep out of reach of children, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses: For the treatment of acnes
Warnings
For external use only
Otc - When Using
- Skin irritation and dryness may occur if you use another topical acne medication at the same time or immediately following.
- If irritation occurs, only use one topical acne medication at a time unless directed by doctor.
Otc - Stop Use
if irritation becomes severe.
Otc - Ask Doctor
if irritation becomes severe.
Otc - Keep Out Of Reach Of Children
if swallowed, get medical help or contact a Poison Control Center right away.
Storage And Handling
Store at room temperature. Avoid use if you have very sensitive skin or anr allergic to Salicylic acid.
Inactive Ingredient
Sodium Hyaluronate, Niacinamide, Oligopeptide-10, Phytosphingosine HCl
Patch : Hydrocolloid
References
Label (Ref)
Dosage & Administration
1. Open the packaging and take out the patch.
2. Carefully remove the white film, ensuring not to touch the center of the patch.
3. Apply the patch directly to the affected area and press vertically with your fingers.
4. Leave on for 2 hours or overnight, then remove.
Indications & Usage
1. Open the packaging and take out the patch.
2. Carefully remove the white film, ensuring not to touch the center of the patch.
3. Apply the patch directly to the affected area and press vertically with your fingers.
4. Leave on for 2 hours or overnight, then remove.
Package Label.Principal Display Panel
* Please review the disclaimer below.
