Sea Breeze Actives Deep-Clean Astringent

Dosage form: liquid
Ingredients: SALICYLIC ACID 1g in 100mL
Labeler: Idelle Labs, Ltd
NDC Code: 41595-3022

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.

Sea Breeze Actives Deep-Clean Astringent

Active ingredient

Salicylic acid 1%

Purpose

Acne medication

Uses
  • for the treatment of acne
  • clears blackheads

Warnings

For external use only.

When using this product
  • and other topical acne medication at the same time or immediately following use of this product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor.

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
  • clean skin thoroughly before applying medication.
  • moisten a cotton ball and smooth the cotton ball over your face one to three times daily.

Inactive ingredients

Benzoic acid, camphor, clove (eugenia caryophyllus) oil, eucalyptus globulus oil, fragrance, glycerin, methyl propanediol, orange 4, PPG-12-buteth-16, SD alcohol 40-B, yellow 5, water.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

label

SEA BREEZE ACTIVES DEEP-CLEAN ASTRINGENT 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-3022
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CAMPHOR (SYNTHETIC) 
CLOVE OIL 
EUCALYPTUS OIL 
GLYCERIN 
METHYLPROPANEDIOL 
D&C ORANGE NO. 4  
PPG-14 BUTYL ETHER  
ALCOHOL 
FD&C YELLOW NO. 5  
WATER 
Packaging
#Item CodePackage Description
1NDC:41595-3022-1295 mL in 1 BOTTLE
2NDC:41595-3022-2474 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/FEIOperations
Marianna Industries, Inc.045570736MANUFACTURE

Revised: 04/2011
 
Idelle Labs, Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)