Selsun Blue Naturals Shampoo - Island Breeze

Drug Labeling and Warnings

Drug Details [pdf]

SELSUN BLUE NATURALS ISLAND BREEZE- salicylic acid shampoo 
Chattem, Inc.

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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Selsun Blue Naturals Shampoo - Island Breeze

Drug Facts
Selsun blue Naturals Island Breeze

Active ingredient

Salicylic Acid 3%

Purpose

Anti-dandruff

Use

for relief of flaking and itching due to dandruff and seborrheic dermatitis, and to help prevent their recurrence

Warnings

For external use only

Ask a doctor before use if you have

• seborrheic dermatitis in areas other than the scalp

When using this product

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• condition worsens or does not improve after regular use of this product as directed

Keep out of reach of children.

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

Directions

• shampoo, then rinse thoroughly
  
• for best results use at least twice a week or as directed by a doctor

Inactive ingredients

water, ammonium laureth sulfate, ammonium lauryl sulfate, sodium methyl cocoyl taurate, cocamidopropyl betaine, cocodimonium hydroxypropyl hydrolyzed rice protein, chamomilla recutita (matricaria) flower extract, lavandula augustifolia (lavender) extract, rosmariunus oficinalis (rosemary) leaf extract, acacia farnesiana flower extract, PEG-10 sunflower glycerides, tocopheryl acetate, aloe barbadensis leaf juice, panthenol, cocamide MEA, fragrance, sodium lauryl glucose carboxylate, benzyl alcohol, lauryl glucoside, polyquaternium-67, linoleaminopropyl PG-dimonium chloride phosphate, potassium hydroxide, citric acid, disodium EDTA, benzophenone-4, isopropyl myristate (283-058)

PRINCIPAL DISPLAY PANEL

Island Breeze
with Aloe
Controls Flakes & Itch
Selsun blue®
DANDRUFF SHAMPOO
salicylic acid 3%
8 Intensive Moisturizers & Botanicals
Plus Vitamins B5 & E
11 FL OZ (325 mL)

SELSUN BLUE NATURALS ISLAND BREEZE 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-6174
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.03 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CHAMOMILE (UNII: FGL3685T2X)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
ROSEMARY (UNII: IJ67X351P9)
VACHELLIA FARNESIANA FLOWER (UNII: 8487B3MG6D)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-6174-1	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2010	08/11/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	11/01/2010	08/11/2017

Labeler - Chattem, Inc. (003336013)

Revised: 8/2017

Document Id: e45b7afc-890f-4996-adac-7bb048482bb0

34390-5

Set id: 936adf9e-ccd7-410e-9d2c-bc81d74816d4

Version: 2

Effective Time: 20170811