2 IN 1 DANDRUFF- pyrithione zinc shampoo 
Foodhold U.S.A.

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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Dandruff Shampoo

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5

Multiple benefit formula to help:

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Green Apple 2 in 1 Dandruff Shampoo + Conditioner

DISTRIBUTED BY FOODOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949 @ 2016 S&S Brands, LLC
Quality Guaranteed or your money back

Principal Display Panel

CAREONE

clean apple 2 in 1 Dandruff shampoo plus conditioner

for all hair types

pyrithione zinc

helps prevent flakes

Compare to Head & Shoulders 2 in 1 Green Apple Dandruff Shampoo + Conditioner*

14.2 FL OZ (420 mL)

image description

612.001/612AC

2 IN 1 DANDRUFF 
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-989
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC CARBONATE (UNII: EQR32Y7H0M)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-989-35 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/06/2016
2 NDC:41520-989-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 12/06/2016
Labeler - Foodhold U.S.A. (809183973)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(41520-989)

Revised: 1/2019
Document Id: 75937634-5b18-4328-a6e7-3dada6c89a05
Set id: 38b2c4ae-2446-4027-9ec3-a3ff9d6db2ab
Version: 5
Effective Time: 20190103
 
Foodhold U.S.A.