SELSUN BLUE NORMAL TO OILY- selenium sulfide shampoo SELSUN BLUE MOISTURIZING- selenium sulfide shampoo SELSUN BLUE 2-IN-1- selenium sulfide shampoo SELSUN BLUE MEDICATED- selenium sulfide shampoo

Selsun Blue Medicated by

Drug Labeling and Warnings

Selsun Blue Medicated by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., CHATTEM, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Selsun Blue Normal to Oily

Active ingredient

Selenium sulfide 1%

Purpose

Antidandruff

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.
  
• for color-treated or permed hair, rinse thoroughly

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

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

Inactive ingredients

water, ammonium lauryl sulfate, ammonium laureth sulfate, cocamidopropyl betaine, magnesium aluminum silicate, fragrance, cocamide DEA, DMDM hydantoin, hydroxypropyl methylcellulose, citric acid, sodium citrate, sodium chloride, titanium dioxide, blue 1 (283-138)

Drug Facts
Selsun Blue Moisturizing

Active ingredient

Selenium sulfide 1%

Purpose

Antidandruff

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.
  
• for color-treated or permed hair, rinse thoroughly

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

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

Inactive ingredients

water, ammonium lauryl sulfate, distearyl phthalic acid amide, ammonium laureth sulfate, sodium chloride, cocamide DEA, dimethicone, aloe barbadensis leaf juice, hydroxypropyl methylcellulose, sodium isostearoyl lactylate, DMDM hydantoin, fragrance, citric acid, sodium citrate, titanium dioxide, blue 1 (283-134)

Drug Facts
Selsun Blue 2-in-1

Active ingredient

Selenium sulfide 1%

Purpose

Antidandruff

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.
  
• for color-treated or permed hair, rinse thoroughly

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

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

Inactive ingredients

water, ammonium lauryl sulfate, distearyl phthalic acid amide, ammonium laureth sulfate, sodium chloride, cocamide DEA, dimethicone, hydroxypropyl methylcellulose, DMDM hydantoin, fragrance, citric acid, sodium citrate (283-133)

Drug Facts
Selsun Blue Medicated

Active ingredient

Selenium sulfide 1%

Purpose

Antidandruff

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.
  
• for color-treated or permed hair, rinse thoroughly

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

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

Inactive ingredients

water, ammonium lauryl sulfate, TEA lauryl sulfate, ammonium laureth sulfate, cocamidopropyl betaine, magnesium aluminum silicate, fragrance, menthol, cocamide DEA, DMDM hydantoin, citric acid, hydroxypropyl methylcellulose, sodium citrate, sodium chloride, blue 1, red 33 (283-139)

PRINCIPAL DISPLAY PANEL

Normal to Oily
for Daily Control
Cleans Without Build-up
Selsun blue®
DANDRUFF SHAMPOO
selenium sulfide 1%
Tough on Dandruff…Great for Hair
Targets the Source to Control Dandruff
7 FL OZ (207 mL)

PRINCIPAL DISPLAY PANEL

Moisturizing
with Aloe
For Dry Scalp & Hair
Selsun blue®
DANDRUFF SHAMPOO
selenium sulfide 1%
Tough on Dandruff…Great for Hair
Targets the Source to Control Dandruff
7 FL OZ (207 mL)

PRINCIPAL DISPLAY PANEL

2-in-1
Cleans and Conditions
Maximum Strength
Selsun blue®
DANDRUFF SHAMPOO
selenium sulfide 1%
Tough on Dandruff…Great for Hair
Targets the Source to Control Dandruff
7 FL OZ (207 mL)

PRINCIPAL DISPLAY PANEL

Medicated
with Menthol
Maximum Strength
Selsun blue®
DANDRUFF SHAMPOO
selenium sulfide 1%
Tough on Dandruff…Great for Hair
Targets the Source to Control Dandruff
7 FL OZ (207 mL)

INGREDIENTS AND APPEARANCE

SELSUN BLUE NORMAL TO OILY 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-6202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SULFATE ION (UNII: 7IS9N8KPMG)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-6202-1	207 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2002	02/22/2021
2	NDC: 41167-6202-3	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2002	02/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	04/01/2002	02/22/2021

SELSUN BLUE MOISTURIZING 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-6032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SULFATE ION (UNII: 7IS9N8KPMG)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-6032-0	207 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2002
2	NDC: 41167-6032-2	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	04/01/2002

SELSUN BLUE 2-IN-1 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1651
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SULFATE ION (UNII: 7IS9N8KPMG)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-1651-4	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2002
2	NDC: 41167-1651-5	207 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2002	01/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	04/01/2002

SELSUN BLUE MEDICATED 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-6061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SULFATE ION (UNII: 7IS9N8KPMG)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MENTHOL (UNII: L7T10EIP3A)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-6061-2	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2002
2	NDC: 41167-6061-3	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2002	06/05/2018
3	NDC: 41167-6061-6	207 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	04/01/2002

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	LABEL(41167-6202, 41167-6032, 41167-1651, 41167-6061) , MANUFACTURE(41167-6202, 41167-6032, 41167-1651, 41167-6061) , PACK(41167-6202, 41167-6032, 41167-1651, 41167-6061)