ANTI DANDRUFF- salicylic acid shampoo 
Orange Lab

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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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

ANTI DANDRUFF 
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71331-106
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)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
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)  
PAULLINIA CUPANA SEED (UNII: C21GE7524R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
C11-15 PARETH-7 (UNII: 261HPE0IS3)  
Product Characteristics
Colorwhite (Pearly White/Yellowish color) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71331-106-09237 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2020
2NDC:71331-106-33946 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03201/01/2020
Labeler - Orange Lab (004862271)
Registrant - Orange Lab (004862271)
Establishment
NameAddressID/FEIBusiness Operations
Orange Lab004862271manufacture(71331-106)

Revised: 1/2023
Document Id: f39454be-f1a2-9877-e053-2a95a90a57ec
Set id: 4a64dc7e-543b-51c7-e054-00144ff8d46c
Version: 5
Effective Time: 20230131
 
Orange Lab