Label: HEAD AND SHOULDERS MENTHOL FRESH- pyrithione zinc lotion/shampoo
- NDC Code(s): 51769-134-40, 51769-134-70
- Packager: ALL NATURAL DYNAMICS
- 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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- WARNINGS AND PRECAUTIONS
- Active ingredient
Pyrithione zinc 1%Close
helps prevent recurrence of flaking and itching associated with dandruff.Close
For external use only.Close
- for best results use at least twice a week or as directed by a doctor.
- for maximum dandruff control, use every time you shampoo.
- wet hair, massage onto scalp, rinse, repeat if desired.
- 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.Close
- KEEP OUT OF REACH OF CHILDREN
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Close
- Inactive ingredients
Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, fragrance, sodium xylenesulfonate, dimethicone, cocamidopropyl betaine, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, pyrithione zinc, blue 1, red 33.Close
- Questions (or comments)?
- INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS MENTHOL FRESH
pyrithione zinc lotion/shampoo
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51769-134 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrithione Zinc (PYRITHIONE ZINC) Pyrithione Zinc 0.01 g in 1 mL Inactive Ingredients Ingredient Name Strength water sodium lauryl sulfate sodium laureth sulfate glycol distearate zinc carbonate sodium chloride sodium xylenesulfonate dimethicone COCO MONOETHANOLAMIDE sodium benzoate magnesium carbonate hydroxide methylchloroisothiazolinone methylisothiazolinone POLYQUATERNIUM-10 (400 MPA.S AT 2%) Cetyl Alcohol Magnesium Sulfate ALOE VERA LEAF Benzyl Alcohol Sodium Xylenesulfonate Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51769-134-40 400 mL in 1 BOTTLE, PLASTIC 2 NDC:51769-134-70 700 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 01/24/2013 Labeler - ALL NATURAL DYNAMICS (962732892) Establishment Name Address ID/FEI Business Operations Procter & Gamble Manufactura, S. de R.L. de C.V. 812807550 manufacture(51769-134)