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acne buster star patch 140 patches - Tea Tree Extract and Salicylic Acid

140 PATCHES (acne buster)

Approved
Approval ID

a94c69ee-70e9-448b-aa8a-556fcbd63885

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code56136-196
Application NumberM006
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic Acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (4)

BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILInactive
Code: VIF565UC2G
Classification: IACT
CALCIUM CARBOXYMETHYL CELLULOSEInactive
Code: UTY7PDF93L
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, Melaleuca Alternifolia (Tea Tree) Leaf Extract. May contain: FD&C Red No. 40 (CI 16035), FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090).

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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