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 WOOSHIN LABOTTACH CO., LTD., 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

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 one medication should be used. Do not use if you are allergic to the dressing or any of its components.

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

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

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: 82957-101
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: 82957-101-11	40 in 1 CARTON	02/07/2023
1		0.25 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 82957-101-12	40 g in 1 POUCH; Type 0: Not a Combination Product	02/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	02/07/2023

Labeler - WOOSHIN LABOTTACH CO., LTD. (688269808)

Registrant - WOOSHIN LABOTTACH CO., LTD. (688269808)

Establishment
Name	Address	ID/FEI	Business Operations
WOOSHIN LAPACHE d.o.o.		507385209	manufacture(82957-101)