Anti Dandruff Shampoo

Anti Dandruff Shampoo

Drug Labeling and Warnings

Drug Details

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SALICYLIC ACID- salicylic acid shampoo 
Orange Lab

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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Anti Dandruff Shampoo

Active Ingredient

Salicylic Acid 2 %

Warnings

Warning section

Purpose

purpose

PREGNANCY OR BREAST-FEEDING

Pregnancy section

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Inactive Ingredients

Inactive ingredients

Directions

Directions

Shampoo description

Enfanti Antidandruff Shampoo

Directions

1

OTC Active Ingredient

Active ingredients

USE:

Principal Display Panel

Enfanti front

SALICYLIC ACID 
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71331-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
MENTHOL (UNII: L7T10EIP3A)  
C12-16 PARETH-9 (UNII: 9DJ758090Y)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
TRIDECETH-12 (UNII: YFY3KG5Y7O)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
WATER (UNII: 059QF0KO0R)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
PAULLINIA CUPANA SEED (UNII: C21GE7524R)  
C11-15 PARETH-7 (UNII: 261HPE0IS3)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
Product Characteristics
Colorwhite (Pearly White/Yellowish color) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71331-101-081 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2017
2NDC: 71331-101-321 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2017
Labeler - Orange Lab (004862271)
Registrant - Orange Lab (004862271)
Establishment
NameAddressID/FEIBusiness Operations
Orange Lab004862271manufacture(71331-101)

Revised: 3/2017
 
Orange Lab


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