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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Drug Facts

Dandruff Care for Great Looking Hair
This product helps relieve scalp dryness,
itch, irritation and helps prevent flakes.
Clean Manageable Hair for Everyday
• Dual Formula cleans and conditions hair in
one easy step
• Gentle and pH balanced for everyday use
-even for permed or colored-treated hair

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 by a doctor

Inactive ingredients water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, cocamidopropyl betaine, fragrance, amodimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

Distributed by: American Sales company
4201 Walden Avenue, Lancaster, NY 14086
1-877-846-9949

Quality guaranteed or your mone back

Principal Display Panel

CAREONE

everyday clean 12 in 1

Dandruff

shampll pls conditioner

for normal hair

pyrithione zinc

14.2 fl 0z (420 mL)

image description

DANDRUFF 
pyrithione zinc lotion/shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-311
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g  in 100 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)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-311-15 420 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 07/09/2004
Labeler - American Sales Company (809183973)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(41520-311)

Revised: 2/2013
Document Id: e0c1af02-6dbf-4d10-844b-3a388301343f
Set id: 9ec441db-dfa8-4677-8d28-f39b0af39b89
Version: 3
Effective Time: 20130205
 
American Sales Company