Label: HEAD AND SHOULDERS EXTRA VOLUME- pyrithione zinc lotion/shampoo
- NDC Code(s): 37000-082-40, 37000-082-70
- Packager: Procter & Gamble Manufacturing Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active ingredient
Pyrithione zinc 1%Close
helps prevent recurrence of flaking and itching associated with dandruff.Close
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.
- for best results use at least twice a week or as directed by a doctor.
- for maximum dandruff control, use every time you shampoo.
- shake before use.
- wet hair, massage onto scalp, rinse, repeat if desired.
- Inactive ingredients
Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, sodium xylenesulfonate, cocamidopropyl betaine, fragrance, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone.Close
- Questions (or comments)?
- SPL UNCLASSIFIED SECTION
Dist. by PROCTER & GAMBLE,Close
CINCINNATI, OH 45202
- PRINCIPAL DISPLAY PANEL - 700 mL Bottle Label
pyrithione zinc dandruff shampoo
24 hour volume boost
23.7 FL OZ
- INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS EXTRA VOLUME
pyrithione zinc lotion/shampoo
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37000-082 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc 1 g in 100 mL Inactive Ingredients Ingredient Name Strength water sodium lauryl sulfate sodium laureth-3 sulfate glycol distearate zinc carbonate sodium chloride sodium xylenesulfonate cocamidopropyl betaine dimethicone sodium benzoate magnesium carbonate hydroxide methylchloroisothiazolinone methylisothiazolinone Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-082-70 700 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160 2 NDC:37000-082-40 400 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160 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)