SELSUN BLUE ACTIVE 3-IN-1- salicylic acid shampoo

Selsun Blue Active 3-in-1 by

Drug Labeling and Warnings

Selsun Blue Active 3-in-1 by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Selsun Blue
3-in-1 Shampoo, Conditioner & Body Wash

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Use

▪ for the treatment of acne

▪ clears up and helps keeps skin clear of new acne blemishes

Warnings

For external use only

When using this product

▪ skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

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

Directions

▪ apply daily to wet or dampened skin and lather

▪ rinse with warm water and pat dry

▪ if bothersome dryness or peeling occurs, reduce application use

Inactive ingredients

water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, glycerin, cocamidopropyl betaine, PEG-10 sunflower glycerides, fragrance, polyacrylate-1 crosspolymer, polysorbate 80, potassium hydroxide, sodium methyl cocoyl taurate, sodium lauryl glucose carboxylate, benzyl alcohol, lauryl glucoside, guar hydroxypropyltrimonium chloride, citric acid, linoleamidopropyl PG-dimonium chloride phosphate, polyquaternium-67, propylene glycol, aloe barbadensis leaf juice, benzophenone-4, panthenol, bisabolol, EDTA, lavandula angustifolia (lavender) extract, tocopheryl acetate, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, acacia farnesiana flower extract, isopropyl myristate, zingiber officinale (ginger) root extract

Selsun Blue
3-in-1 Shampoo, Conditioner & Body Wash

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Antidandruff

Use

▪ fights scalp itching, flaking and irritation associated with dandruff

Warnings

For external use only

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

▪ wet hair thoroughly

▪ massage onto scalp

▪ rinse well

▪ for best results use at least twice a week or as directed by a doctor

Inactive ingredients

water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, glycerin, cocamidopropyl betaine, PEG-10 sunflower glycerides, fragrance, polyacrylate-1 crosspolymer, polysorbate 80, potassium hydroxide, sodium methyl cocoyl taurate, sodium lauryl glucose carboxylate, benzyl alcohol, lauryl glucoside, guar hydroxypropyltrimonium chloride, citric acid, linoleamidopropyl PG-dimonium chloride phosphate, polyquaternium-67, propylene glycol, aloe barbadensis leaf juice, benzophenone-4, panthenol, bisabolol, EDTA, lavandula angustifolia (lavender) extract, tocopheryl acetate, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, acacia farnesiana flower extract, isopropyl myristate, zingiber officinale (ginger) root extract

PRINCIPAL DISPLAY PANEL

Active 3-in-1
Body Wash +
Shampoo + Conditioner
Selsun
blue
DANDRUFF SHAMPOO
ACNE TREATMENT BODY WASH
Salicylic acid 2%
11 FL OZ (325 mL)

 

INGREDIENTS AND APPEARANCE

SELSUN BLUE ACTIVE 3-IN-1 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-6152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYQUATERNIUM-68 (UNII: R76MNN6P72)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULISOBENZONE (UNII: 1W6L629B4K)
PANTHENOL (UNII: WV9CM0O67Z)
LEVOMENOL (UNII: 24WE03BX2T)
EDETIC ACID (UNII: 9G34HU7RV0)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHAMOMILE (UNII: FGL3685T2X)
ROSEMARY (UNII: IJ67X351P9)
VACHELLIA FARNESIANA FLOWER (UNII: 8487B3MG6D)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-6152-0	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2017
2	NDC: 41167-6152-2	10 mL in 1 PACKET; Type 0: Not a Combination Product	11/09/2017	03/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	11/09/2017

Labeler - Chattem, Inc. (003336013)