LaboFlex Acne Spot Care by WOOSHIN LABOTTACH CO., LTD. / WOOSHIN LAPACHE d.o.o. Laboflex Acne Spot Care

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]

LABOFLEX ACNE SPOT CARE- salicylic acid 0.5% patch 
WOOSHIN LABOTTACH CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Laboflex Acne Spot Care

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

Carton

Label

LABOFLEX ACNE SPOT CARE 
salicylic acid 0.5% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82957-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82957-101-1140 in 1 CARTON02/07/2023
10.25 g in 1 PATCH; Type 0: Not a Combination Product
2NDC: 82957-101-1240 g in 1 POUCH; Type 0: Not a Combination Product02/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00602/07/2023
Labeler - WOOSHIN LABOTTACH CO., LTD. (688269808)
Registrant - WOOSHIN LABOTTACH CO., LTD. (688269808)
Establishment
NameAddressID/FEIBusiness Operations
WOOSHIN LAPACHE d.o.o.507385209manufacture(82957-101)

Revised: 2/2023