Label: HEAD AND SHOULDERS DAMAGE RESCUE- pyrithione zinc lotion/shampoo
- NDC Code(s): 37000-058-40, 37000-058-70
- 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.
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
Pyrithione zinc 1%Close
helps prevent recurrence of flaking and itching associated with dandruff.Close
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, sodiumlaureth sulfate, sodiumlauryl sulfate, dimethicone, cocamideMEA, zinc carbonate, glycol distearate, sodiumxylenesulfonate, fragrance, cetyl alcohol, guar hydroxypropyltrimoniumchloride,magnesiumsulfate, sodium chloride, sodium benzoate,magnesiumcarbonate hydroxide, benzyl alcohol, tocopheryl acetate,methylchloroisothiazolinone,methylisothiazolinone, yellow 5, orange 4.Close
- Questions (or comments)?
- SPL UNCLASSIFIED SECTION
Dist. by PROCTER & GAMBLE,Close
CINCINNATI, OH 45202
- PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label
pyrithione zinc dandruff shampoo
rescue hair from damage, dullness,
and scalp dryness
13.5 FL OZ
- INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS DAMAGE RESCUE
pyrithione zinc lotion/shampoo
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37000-058 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 Laureth-3 Sulfate Sodium Lauryl Sulfate Dimethicone Coco Monoethanolamide Zinc Carbonate Glycol Distearate Sodium Xylenesulfonate Cetyl Alcohol Magnesium Sulfate Sodium Chloride Sodium Benzoate Magnesium Carbonate Hydroxide Benzyl Alcohol .Alpha.-Tocopherol Acetate Methylchloroisothiazolinone Methylisothiazolinone FD&C Yellow No. 5 D&C Orange No. 4 Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-058-40 400 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160 2 NDC:37000-058-70 700 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 05/15/2012 Labeler - Procter & Gamble Manufacturing Co. (004238200)