ANTI DANDRUFF- salicylic acid shampoo 
The Hain Celestial Group, 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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For external use only. Avoid contact with eyes. Rinse eyes throughly with water in case contact ossurs. Discontinue to use and contact your physician if irritation develops.

Drug Facts

Salicylic Acid    2.0%

Controls symptoms of dandruff, seboric dermatitis and psoriasis

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

For relief of flaking, scaling and itching associated with dandruff. Helps prevent Seborrheic Dermatitis

For the best results use at least three times each week. Wet hair, lather, massage onto scalp. Rinse and repeat if desired.

Aloe Barbadensis Leaf Juice (1),Aqua (Water), Sodium Coco-Sulfate, Cococ-Glucoside, Glyceryl Oleate, Chamomilla Recuitita (Matricaria) Flower Extract (1), Malaleuca Alternifolia (Tea Tree) Leaf Oil (1), Rosmarinus Officinalis (Rosemary) extract, Styrax Benzoin Resin Extract (1), Canarium Luzonicum Gum Nonvolatiles, Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange Peel Oil, Citrus Limon (Lemon) Peel Oil,

bottle label

ANTI DANDRUFF 
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.0 g  in 414 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
COCO GLUCOSIDE (UNII: ICS790225B)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
CHAMOMILE (UNII: FGL3685T2X)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
CANARIUM LUZONICUM WHOLE (UNII: 5BH1ESR432)  
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
ORANGE OIL (UNII: AKN3KSD11B)  
LEMON OIL (UNII: I9GRO824LL)  
COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)  
CORIANDER OIL (UNII: 7626GC95E5)  
GERANIUM MACULATUM WHOLE (UNII: LFG25P7V8M)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
POGOSTEMON CABLIN WHOLE (UNII: H6UKY25H2P)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
INULIN (UNII: JOS53KRJ01)  
MENTHOL (UNII: L7T10EIP3A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-1106-9414 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/29/2014
Labeler - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture(61995-1106)

Revised: 1/2014
Document Id: d7a25e70-c31d-4d68-bd26-6e9ba37fc463
Set id: 3efbb5a6-0a45-47f1-a769-04455256918d
Version: 1
Effective Time: 20140128
 
The Hain Celestial Group, Inc.