Label: HEAD AND SHOULDERS 3 IN 1 MEN- head and shoulders lotion/shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 72389-106-02, 72389-106-03 - Packager: ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.
- 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 January 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Purpose
Deeply Cleanses 3 Action formula TM
Protects hair against dandruff
Softens hair
*Up to 100% dandruff free
With Regular use, H&S 3action formula cleans, protects and hydrates hair and scalf.
The DermaSense balanced pH formula, eliminates up to 100% of dandruff trace*, takes care of your scalp and leaves your hair
beautiful,
*Visible dandruff, using it often.
- Active Ingredient
- Warnings
- When using this product
- Stop use and ask doctor if
- Keep our of reach of children
- Directions
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Inactive Ingredients
Water, sodium laureth sulfate, sodium laurylsulfate, dimethicone, cocamide MEA, zinc carbonate, glycol distearate,
sodium xylenesulfonate, fragrance, cetyl alcohol,
guarhydroxypropyltrimonium chloride, hydrochloric acid,, magnesium sulfate, sodium chloride,sodium benzoate,limonene,
linalool, magnesium carbonate hydroxide, benzyl alcohol, methylchloroisothiazolinone,
FD&C Blue 1, methylisothiaolinone, D&C Red No 33
- Distributed by:
- Indications:
- Principal Display Panel Antidandruff Shampoo 3 in 1 MEN
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS 3 IN 1 MEN
head and shoulders lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72389-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g in 100 mL Inactive Ingredients Ingredient Name Strength COCO MONOETHANOLAMIDE (UNII: C80684146D) CETYL ALCOHOL (UNII: 936JST6JCN) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) LIMONENE, (+)- (UNII: GFD7C86Q1W) D&C RED NO. 33 (UNII: 9DBA0SBB0L) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) GLYCOL DISTEARATE (UNII: 13W7MDN21W) LINALOOL, (-)- (UNII: 3U21E3V8I2) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM BENZOATE (UNII: OJ245FE5EU) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) HYDROCHLORIC ACID (UNII: QTT17582CB) ZINC CARBONATE (UNII: EQR32Y7H0M) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72389-106-02 375 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/27/2018 2 NDC:72389-106-03 180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/27/2018 Labeler - ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. (812839648) Registrant - ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. (815333653) Establishment Name Address ID/FEI Business Operations PROCTER & GAMBLE MANUFACTURING MEXICO, S. DE R.L. DE C.V. 812807550 manufacture(72389-106) Establishment Name Address ID/FEI Business Operations ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. 812839648 label(72389-106)
