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my beauty spot BLEMISH DOTS - CHARCOAL (10 PATCHES)

10 PATCHES (BLEMISH DOTS)

Approved
Approval ID

cf36f10f-015d-491e-b8b9-99e130f67deb

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

Ganzhou Olivee Cosmetic Co., Ltd.

DUNS: 543008195

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Salicylic Acid 0.5%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code56136-195
Application NumberM006
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic Acid 0.5%
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (3)

ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
SALICYLIC ACIDActive
Quantity: 0.5 g in 100 g
Code: O414PZ4LPZ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Product Packaging

Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Uses

soothe and help diminish the redness and irritation of blemished skin and a sorbs excess oil for faster healing.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/1/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active Ingredients

Salicylic Acid 0.5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Purpose

Acne Treatment

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

Directions

  • Cleanse and dry facem, removing and makeup.
  • Apply one healing dot, sticky side down, over your blemish.
  • Leave the healing dot over blemish for at least 6 hours or overnight
  • Repeat as necessary with a new healing dot.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Inactive Ingredients

Calcium Carboxymethyl Cellulose, polysilicone-2, Butylene Glycol. Polyurethane-42, Aloe Barbadensis Leaf Extract, Charcoal Extract

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

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

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my beauty spot BLEMISH DOTS - CHARCOAL (10 PATCHES) - FDA Drug Approval Details