LABOFLEX ACNE SPOT CARE- salicylic acid 0.5% patch

LABOFLEX Acne Spot Care by

Drug Labeling and Warnings

LABOFLEX Acne Spot Care by is a Otc medication manufactured, distributed, or labeled by Laboflex, Inc., WOOSHIN LAPACHE d.o.o.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Salicylic Acid 0.5%

Purpose

Acne Treatment

Uses

• For the treatment of acne

Directions

• Cleanse thoroughly before applying this product
• Cover the entire affected area with patch
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor
• If bothersome dryness or peeling occurs, reduce application to once a day or even every other day

Inactive Ingredients

Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Sodium, Glycerin, Methyl- paraben, Mint Oil, Partially Neutralized Polyacrylic Acid, Polysorbate 80, Povidone-K90, Propylparaben, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Purified Water

Questions of comments?

Call toll-free 1-800-655-0252 or email: wooshinlabo-us@wooshinmed.com

Warnings

For external use only.

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

Product Packaging

INGREDIENTS AND APPEARANCE

LABOFLEX ACNE SPOT CARE 
salicylic acid 0.5% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83655-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MINT (UNII: FV98Z8GITP)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
WATER (UNII: 059QF0KO0R)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83655-105-21	40 in 1 CARTON	09/27/2023
1		0.25 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 83655-105-11	30 in 1 POUCH	09/27/2023
2		0.25 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	09/27/2023

Labeler - Laboflex, Inc. (128394050)

Registrant - Laboflex, Inc. (128394050)

Establishment
Name	Address	ID/FEI	Business Operations
WOOSHIN LAPACHE d.o.o.		507385209	manufacture(83655-105)