MODESA 2 IN 1 DANDRUFF ALMOND OIL DRY SCALP- pyrithione zinc shampoo

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)
Available from:
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Help prevent to treat flakes, itch, irritation, oilness or dryness caused by dandruff. wet hair, squeeze small amount to palm, lather, rinse well for best results use at least twice a week or as directed by a doctor.
Authorization status:
OTC monograph final
Authorization number:
40104-432-01

MODESA 2 IN 1 DANDRUFF ALMOND OIL DRY SCALP- pyrithione zinc shampoo

NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.

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.

----------

Active Ingredient Purpose

Pyrithione Zinc 1.00% Anti-dandruff

Help prevent to treat flakes, itch, irritation, oilness or dryness caused by dandruff.

If swallowed, get medical help or contact a Poison Control Center

1-800-222-1222 right away.

Avoid contact with eyes, if contact occurs rinse eyes with plenty of water.

wet hair, squeeze small amount to palm, lather, rinse well for best results use at least twice a week or as

directed by a doctor.

For external use only.

Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.

small amount to palm, or as directed by a doctor.

water, sodium laureth sulfate, sodium lauryl sulfate, glycol distearate, sodium chloride, zinc barbonate,

sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar

hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, prunus amygdalus

dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone.

MODESA 2 IN 1 DANDRUFF ALMOND OIL DRY SCALP

pyrithione zinc shampoo

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:40 10 4-432

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PYRITHIO NE ZINC (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9 53O2RHZ5)

PYRITHIONE ZINC

1 g in 10 0 g

NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.

Inactive Ingredients

Ingredient Name

Stre ng th

wa ter (UNII: 0 59 QF0 KO0 R)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

GLYCO L DISTEARATE (UNII: 13W7MDN21W)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

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

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

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

CITRIC ACID, 1-STEARYL ESTER (UNII: E9 45AJ51FA)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:40 10 4-432-0 1 39 6 .9 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 2/20 19

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

0 4/0 2/20 19

Labeler -

NINGBO PULISI DAILY CHEMICAL PRODUCT S CO., LT D. (529047265)

Registrant -

NINGBO PULISI DAILY CHEMICAL PRODUCT S CO., LT D. (529047265)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.

529 0 4726 5

ma nufa c ture (40 10 4-432)

Revised: 4/2019

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