DANDRUFF- pyrithione zinc lotion/shampoo 
American Sales Company

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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Care One 311

claims

Multiple benefit formula to help:

  • Fight dry scalp
  • Calm itch
  • Relieve irritation
  • Soothe and reduce redness
  • Redce oiliness
  • Prevent flakes
  • Leave hair healthy looking

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

  • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • condition worsens or does not improve after regular use as directed.

Keep out of reach of children

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

Directions

  • shake well
  • for maximum dandruff control, use every time you shampoo
  • wet hair, massage onto scalp, rinse, repeat if desired
  • for best results use at least twice a week or as directed

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, red 33

Disclaimer

This product is not manufactured or distributed by Procter & Gamble, the distributor of Head & Shoulders Classic clean 2 in 1 Dandruff Shampoo & Conditioner

Adverse reactions

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949  2016  S&S Brands, LLC

Quality guaranteed or your money back.

311.007/311AL

principal display panel

CAREONE

everyday clan 2 in 1

Dandruff

shampoo

plus conditioner

for normal hair

pyrithione zinc

helps prevent flakes

Compare to Head & Shoulders

2 in 1 Classic Clean Dandruff

Shampoo + Conditioner

14.2 FL OZ (420 mL)

image description

DANDRUFF 
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-311
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-311-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/200408/27/2020
2NDC:41520-311-35700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/200408/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/09/200408/27/2020
Labeler - American Sales Company (809183973)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(41520-311)

Revised: 8/2020
 
American Sales Company