Sea Breeze Actives Deep-Clean Astringent: Package Insert and Label Information

SEA BREEZE ACTIVES DEEP-CLEAN 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.

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

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

label

SEA BREEZE ACTIVES DEEP-CLEAN ASTRINGENT
salicylic acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41595-3022
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Multilevel Packaging
1 NDC:41595-3022-1 295 mL in 1 BOTTLE None
2 NDC:41595-3022-2 474 mL in 1 BOTTLE None
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 Operations
Marianna Industries, Inc. 045570736 MANUFACTURE

Revised: 04/2011 Idelle Labs, Ltd

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.