HEAD AND SHOULDERS  GREEN APPLE- pyrithione zinc lotion/shampoo 
Procter & Gamble Manufacturing Co.

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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Head and Shoulders®
Green Apple

Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

When using this product

  • avoid contact with 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 of this product as directed.

Keep this and all drugs 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, zinc carbonate, sodium chloride, sodium xylenesulfonate, cocamidopropyl betaine, dimethicone, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 700 mL Bottle Label

NEW
fresh scent
technology

head &
shoulders®

pyrithione zinc dandruff shampoo

green apple

fights dandruff with
a crisp clean scent

FLAKE FREE.*
100%
GUARANTEED^

23.7 FL OZ
(700 mL)

96220925

Principal Display Panel - 700 mL Bottle Label
HEAD AND SHOULDERS   GREEN APPLE
pyrithione zinc lotion/shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-077
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-3 sulfate (UNII: BPV390UAP0)  
glycol distearate (UNII: 13W7MDN21W)  
zinc carbonate (UNII: EQR32Y7H0M)  
sodium chloride (UNII: 451W47IQ8X)  
sodium xylenesulfonate (UNII: G4LZF950UR)  
cocamidopropyl betaine (UNII: 5OCF3O11KX)  
dimethicone (UNII: 92RU3N3Y1O)  
sodium benzoate (UNII: OJ245FE5EU)  
magnesium carbonate hydroxide (UNII: YQO029V1L4)  
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:37000-077-10 10 mL in 1 POUCH; Type 0: Not a Combination Product
2 NDC:37000-077-70 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3 NDC:37000-077-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part358H 09/01/2013
Labeler - Procter & Gamble Manufacturing Co. (004238200)

Revised: 9/2014
Document Id: 76f264f1-b6c0-466c-8760-13223b3f307e
Set id: a296e74c-bc52-4406-a161-aff935288cd4
Version: 2
Effective Time: 20140909
 
Procter & Gamble Manufacturing Co.