SEA BREEZE ACTIVES CLEAR-PORE ASTRINGENT- salicylic acid liquid 
Idelle Labs, 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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Sea Breeze Actives Clear-Pore Astringent

Active ingredient

Salicylic acid 2%

Purpose

Acne medication

Uses

Warnings

For external use only.

When using this product

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Flammable,

keep away from open fire or flame.

Directions

Inactive ingredients

Benzoic acid, camphor, clove (eugenia caryophyllus) oil, eucalyptus globulus oil, Ext. violet 2, fragrance, glycerin, methyl propanediol, PPG-12-buteth-16, SD alcohol 40-B, sodium benzoate, water.

Questions or comments?

1-800-487-7273 or visit us at www.seabreezeclean.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

label

SEA BREEZE ACTIVES CLEAR-PORE ASTRINGENT 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-3020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CLOVE OIL (UNII: 578389D6D0)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41595-3020-1295 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D02/01/2003
Labeler - Idelle Labs, Ltd (128822926)
Registrant - Idelle Labs, Ltd (128822926)
Establishment
NameAddressID/FEIBusiness Operations
Marianna Industries, Inc.045570736MANUFACTURE

Revised: 4/2011
Document Id: af88c848-2eb4-48f0-8bac-b13b2c5b5bd4
Set id: af88c848-2eb4-48f0-8bac-b13b2c5b5bd4
Version: 1
Effective Time: 20110413
 
Idelle Labs, Ltd