CLEAR MEN OCEAN MINERAL ANTIDANDRUFF

Main information

  • Trade name:
  • CLEAR MEN OCEAN MINERAL ANTIDANDRUFF- pyrithione zinc shampoo
  • Composition:
  • Pyrithione Zinc 1.0 g in 100 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLEAR MEN OCEAN MINERAL ANTIDANDRUFF- pyrithione zinc shampoo
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Purpose: Anti-Dandruff Use : helps prevent and control recurrence of itching and flaking associated with dandruff

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 64942-1312-1
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

CLEAR MEN OCEAN MINERAL ANTIDANDRUFF- pyrithione zinc shampoo

Conopco Inc. d/b/a Unilever

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.

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Clear Men Ocean Mineral Anti Dandruff Shampoo and Conditioner

Active Ingredient:

Pyrithione Zinc (1.0%)

Purpose:

Anti-Dandruff

Use: helps prevent and control recurrence of itching and flaking associated with dandruff

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.

Directions:

Wet hair, massage into scalp, rinse. Repeat if desired. For best results use at least twice a week or as

directed by a doctor.

Inactive Ingredients:

Questions, comments?: 1-800-372-6389

PDP 12.9

12.9 PDP back

CLEAR MEN OCEAN MINERAL ANTIDANDRUFF

pyrithione zinc shampoo

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 49 42-1312

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Pyrithio ne Zinc (UNII: R9 53O2RHZ5) (Pyrithio ne Zinc - UNII:R9 53O2RHZ5)

Pyrithio ne Zinc

1.0 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SO DIUM LAURO YL ISETHIO NATE (UNII: M59 0 0 21Z0 2)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

TRIETHANO LAMINE DO DECYLBENZENESULFO NATE (UNII: 8 HM7ZD48 HN)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

PPG-9 (UNII: I29 VQH0 G0 B)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

SPEARMINT O IL (UNII: C3M8 146 5G5)

GUAR HYDRO XYPRO PYLTRIMO NIUM CHLO RIDE ( 1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16 G315W7A)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

ZINC SULFATE (UNII: 8 9 DS0 H9 6 TB)

DIMETHICO NO L ( 4 1 MPA.S) (UNII: 343C7U75XW)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

SO DIUM ISETHIO NATE (UNII: 3R36 J71C17)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

LAURETH-2 3 (UNII: N72LMW56 6 G)

LAURETH-4 (UNII: 6 HQ8 5579 8 J)

.ALPHA.-TO CO PHERO L ACETATE, D- (UNII: A7E6 112E4N)

ALMO ND O IL (UNII: 6 6 YXD4DKO9 )

PO LYETHYLENE GLYCO L 4 0 0 0 0 0 (UNII: 439 X29 GCJZ)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

LYSINE HYDRO CHLO RIDE (UNII: JNJ23Q2COM)

HYDRO GENATED CO CO NUT O IL (UNII: JY8 1OXM1OM)

SO YBEAN O IL (UNII: 241ATL177A)

XANTHAN GUM (UNII: TTV12P4NEE)

ASIAN GINSENG (UNII: CUQ3A77YXI)

TEA TREE O IL (UNII: VIF56 5UC2G)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

NYMPHAEA ALBA FLO WER (UNII: 40 KQ7Q535O)

SPIRULINA MAXIMA (UNII: 9 K7IG15M0 Q)

MENTHA AQ UATICA LEAF (UNII: 5M10 6 ME6 PT)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 49 42-1312-1

38 1 mL in 1 CONTAINER

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

12/0 1/20 13

Conopco Inc. d/b/a Unilever

Labeler -

Conopco Inc. d/b/a Unilever (001375088)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Unilever Supply Chain Co . d/b/a Unilever

0 43510 0 56

ma nufa c ture (6 49 42-1312)

Revised: 9/2013