SPOT ON ACNE PATCH- salicylic acid patch

Spot On Acne Patch by

Drug Labeling and Warnings

Spot On Acne Patch by is a Otc medication manufactured, distributed, or labeled by ACNEFREE, LLC, Kovas Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

USE

for treatment of acne

WARNINGS

For external use only

Do not use

Do not use if you are allergic to the patch or any of its components

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Stop use and ask a doctor if skin irritation occurs.

Directions

Cleanse and thoroughly dry your face. Remove patch adn apply directly onto the blemish. Leave patch on for at least 6 hours. Best used within 10 days after opening.

Inactive Ingredients

Acrylates Copolymer, Water, Denatured Alcohol , Vinyl Caprolactam/ VP/Dimethylaminoethyl Methacrylate Copolymer, Butylene Glycol, Epilobium Angustifolium Flower/Leaf/Stem Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Vitis Vinifera (Grape) Seed Extract, Volcanic Ash, Kaolin, PVP, Phenoxyethanol, Polysorbate 80, Sodium Hyaluronate, Sodium Metabisulfite, Phytosphingosine.

Purpose

Package label

INGREDIENTS AND APPEARANCE

SPOT ON ACNE PATCH 
salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80861-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.24 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)
HYALURONIC ACID (UNII: S270N0TRQY)

Product Characteristics
Color		Score
Shape		Size	11mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-111-01	36 in 1 CARTON; Type 0: Not a Combination Product	04/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	04/24/2023

Labeler - ACNEFREE, LLC (122237140)

Establishment
Name	Address	ID/FEI	Business Operations
Kovas Co., Ltd		688783559	manufacture(80861-111)