Label: HEAD AND SHOULDERS BREAKEGE PREVENTION- pyrithione zinc 1% lotion/shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 69772-141-11, 69772-141-18, 69772-141-20, 69772-141-40, view more69772-141-50 - Packager: TERESA CECENA DBA GENESIS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 12, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- USER SAFETY WARNINGS
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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.
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
water, sodium laureth sulfate, sodium lauryl sulfate. Coco monoethanolamide, zinc carbonate, glycol distearate, dimethicone, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, benzyl alchohol, tocopheryl acetate, FD&C yellow No5, methylchloroisothiazolinonone, methyllisothiazolinone, FD&C blue No 1
- PRINCIPAL DISPLAY PANEL
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS BREAKEGE PREVENTION
pyrithione zinc 1% lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69772-141 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.01 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCO MONOETHANOLAMIDE (UNII: C80684146D) BENZYL ALCOHOL (UNII: LKG8494WBH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ZINC CARBONATE (UNII: EQR32Y7H0M) GLYCOL DISTEARATE (UNII: 13W7MDN21W) DIMETHICONE (UNII: 92RU3N3Y1O) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) MAGNESIUM SULFATE (UNII: DE08037SAB) SODIUM BENZOATE (UNII: OJ245FE5EU) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69772-141-50 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/12/2015 2 NDC:69772-141-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/12/2015 3 NDC:69772-141-20 200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/12/2015 4 NDC:69772-141-11 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/12/2015 5 NDC:69772-141-18 1180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/12/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 05/12/2015 Labeler - TERESA CECENA DBA GENESIS (078760958) Registrant - Teresa Cecena (078760958) Establishment Name Address ID/FEI Business Operations PROCTER AND GAMBLE MANUFACTURA S. DE R.L. DE C.V. 812807550 manufacture(69772-141)
