Label: ROYAL DANDRUFF DRY SCALP CARE- pyrithione zinc shampoo
- NDC Code(s): 50438-300-01
- Packager: Filo America
- 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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- ACTIVE INGREDIENT
Active Ingredient Purpose
Pyrithione Zinc 1% Anti-dandruffClose
Help prevent the scalp's natural moisture balance and gives you great looking hair.Close
- KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center right away.
Do not get into eyes, if contact occurs, rinse eyes thoroughly with water.Close
- INDICATIONS & USAGE
Shake well, wet hair, massage onto scalp. Rinse, repeat if desired.
For best results, use at least twice a week or as directed by a doctor.
For maximum dandruff control, use every time you shampoo.Close
For external use only.
Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.Close
- DOSAGE & ADMINISTRATION
apply as needed.Close
- INACTIVE INGREDIENT
water, sodium laureth sulfate, cocamidopropyl betaine, sodium lauroamphoacetate, glycol stearate, acrylates/acrylamide copolymer, ammonium chloride, methylchloroisothiazolinone, methylisothiazolinone, fragrance, citric acid, guar hydroxypropyltrimonium chloride, titanium dioxide, disodium EDTA, zinc chloride, blue 1, yellow 5Close
- INGREDIENTS AND APPEARANCE
ROYAL DANDRUFF DRY SCALP CARE
pyrithione zinc shampoo
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50438-300 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 cocamidopropyl betaine glycol stearate CARBOMER COPOLYMER TYPE A ammonium chloride methylchloroisothiazolinone methylisothiazolinone CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50438-300-01 350 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/17/2013 Labeler - Filo America (943873703) Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265) Establishment Name Address ID/FEI Business Operations NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265 manufacture(50438-300)