Label: KLEER-PLEX TARGETED ACNE PEN- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 37945-894-05 - Packager: Bio-Medical & Pharmaceutical Manufacturing Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 13, 2022
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- Drug Facts
- Active Ingredients
- Purpose
- Use
- Warnings
- When using this product
- Keep out of reach of children
- Directions
- Sensitivity test for a new user
- Inactive Ingredients
- Questions or comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KLEER-PLEX TARGETED ACNE PEN
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37945-894 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength BRUCINE SULFATE (UNII: KY7O12XPOQ) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) PEPPERMINT OIL (UNII: AV092KU4JH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WHEAT GERM OIL (UNII: 14C97E680P) GLYCOLIC ACID (UNII: 0WT12SX38S) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37945-894-05 1 in 1 BOX 10/22/2014 09/01/2021 1 15 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/22/2014 Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356) Establishment Name Address ID/FEI Business Operations Bio-Medical & Pharmaceutical Manufacturing Corporation 072186356 manufacture(37945-894)