ANTI DANDRUFF- salicylic acid rinse 
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. Apply to clean, wet hair. Rinse throughly.

Aloe Barbadensis Leaf Juice (1), Aqua (Water), Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Stearic Acid,Cetyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Helianthus Annuus (Sunflower Seed Oi (1), Diheptyl Succinate, Stearyl Alcohol, Olea Europaea (Olive) Fruit Oil (1l, Simmondsia Chinensis (Jojoba) Seed Oil (1), Butyrospermum Parkii (Shea) Butter (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Eucalyptus Globulus Leaf Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract (1), Rosmarinus Officinalis (Rosemmary) Leaf Extract (1), Styrax Benzoin Resin Extract, Malaleuca Alternifolia (Tea Tree) Leaf Oil (1), Rosmarinus Officinalis (Rosemary) Leaf Oil , Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange Peel Oil, Citrus Limon (Lemon) Peel Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Coriandrum Sativum (Coriander) Fruit Oil, Geranium Maculatum Oil, Lavandula Angustifolia  (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Pogostemon Cablin Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Wheat Protein, Menthol, Tocopheryl Acetate, Xanthan Gum, Alcohol, Benzyl Alcohol, Sodium Benzoate, Potassium Sorbate

(1) Certified Organic Ingredients

bottle label

ANTI DANDRUFF 
salicylic acid rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.0 g  in 397 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
JOJOBA OIL (UNII: 724GKU717M)  
SHEA BUTTER (UNII: K49155WL9Y)  
CHAMOMILE (UNII: FGL3685T2X)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
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 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)  
MENTHOL (UNII: L7T10EIP3A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-1107-9397 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/17/2014
Labeler - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture(61995-1107)

Revised: 2/2014
Document Id: 6c2a2513-2af4-4673-9212-630670f0c91c
Set id: e5b6877a-1417-4e88-a62d-76716ba2a92a
Version: 1
Effective Time: 20140204
 
The Hain Celestial Group, Inc.