PREMIUM NOTAMO- pnathenol, salicylic acid shampoo 
HELLO INTERNATIONAL

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Salicylic Acid (0.25%)
Panthenol (0.2%) 

antiseborrheic
hair tonic 

Keep out of reach of children
- Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Helps prevent hair loss and thicken hair. Keeps scalp clean, healthy and smooth.

For external use only
Do not use on damaged or broken scalp
When using this product
 Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask doctor if rash or irritation on scalp develops and lasts.
Store at room temperature 

Directions
Wet your hair and scalp with timid water enough. Apply adequate amount on the palm of the hands, and massage scalp gently with the fingertips. Rinse with clean water.

L-Menthol, Sodium Laureth Sulfate, Ammonium lauryl Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Houttuunia Cordata Extract, Green tea Extract, Perilla Extract, Thujae Orientalis Cacumen, Hibiscus Syriacus Bark Extract, PEG-7 Glyceryl Cocoate, Dimethicone, Hydrolyzed Soybean Protein, Copper peptide 100, polyquaternium-10, Citric Acid, Guar Hydroxypropyltrimonium Chloride, Lawsonia lnermis (Henna) Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Panax Ginseng Root Extract, Swertia Japonica Extract, Disodium EDTA, Glyceryl Stearate, Benzophenone-9, Methylchloroisothiazolinone/Methylisothazolinone, Caramel, Perfume

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PREMIUM NOTAMO 
pnathenol, salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69709-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.002   in 400 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.0025   in 400 mL
Inactive Ingredients
Ingredient NameStrength
LEVOMENTHOL (UNII: BZ1R15MTK7)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
HIBISCUS SYRIACUS BARK (UNII: U6PQI719P3)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
Dimethicone (UNII: 92RU3N3Y1O)  
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
SWERTIA JAPONICA WHOLE FLOWERING (UNII: 01X0P6GX6C)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Benzophenone-9 (UNII: 7925W14T4L)  
Caramel (UNII: T9D99G2B1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69709-103-021 in 1 CARTON
1NDC:69709-103-01400 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/29/2016
Labeler - HELLO INTERNATIONAL (689062090)
Registrant - HELLO INTERNATIONAL (689062090)
Establishment
NameAddressID/FEIBusiness Operations
HELLO INTERNATIONAL689062090manufacture(69709-103)

Revised: 3/2016
Document Id: 7b612640-35a2-4e14-b031-1aa2ae8d6a79
Set id: 62cd741d-318e-40eb-bf5a-19cfabc5ff78
Version: 2
Effective Time: 20160307
 
HELLO INTERNATIONAL