Label: SEA BREEZE ACTIVES DEEP-CLEAN ASTRINGENT- salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 41595-3022-1, 41595-3022-2 - Packager: Idelle Labs, Ltd
- 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 April 19, 2011
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- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Keep out of reach of children.
- Flammable,
- Directions
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SEA BREEZE ACTIVES DEEP-CLEAN ASTRINGENT
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41595-3022 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 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CLOVE OIL (UNII: 578389D6D0) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) METHYLPROPANEDIOL (UNII: N8F53B3R4R) D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U) PPG-14 BUTYL ETHER (UNII: R199TJT95T) ALCOHOL (UNII: 3K9958V90M) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41595-3022-1 295 mL in 1 BOTTLE 2 NDC:41595-3022-2 474 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 02/01/2003 Labeler - Idelle Labs, Ltd (128822926) Registrant - Idelle Labs, Ltd (128822926) Establishment Name Address ID/FEI Business Operations Marianna Industries, Inc. 045570736 MANUFACTURE