ZINC- zinc soap soap
Meixin Beauty & Health Care 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.

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78565-007
Zinc soap

Active Ingredient(s)

Pyrithione Zinc 2.0%

Purpose

Dandruff, Seborrheic dermatitis

Warnings

For external use only

Do not use

Avoid contact with eyes

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 as directed

Keep Out of Reach of Children

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

Directions

Use on affected areas in place of your regular soap.

For best results use at least twice a week or as directed by a doctor.

Work up a lather using warm water and massage into affected areas.

Rinse well.

Other information

Store at room temperature

Inactive ingredients

Sodium Palmitate , Sodium Palm Kernelate , Water , Glycerin ,Tetrasodium EDTA . Aloe Vera Extract

Controls , reduces , and helps stop the symptoms of dandruff and seborrheic dermatitis

Package Label - Principal Display Panel

120g 78565-007-01

ZINC
zinc soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78565-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM PALMITATE (UNII: JQ43KP6296)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78565-007-02	240 g in 1 BOX; Type 0: Not a Combination Product	12/25/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	12/15/2021

Labeler - Meixin Beauty & Health Care Products Co., Ltd. (421458605)

Name	Address	ID/FEI	Business Operations
Establishment
Meixin Beauty & Health Care Products Co., Ltd.		421458605	manufacture(78565-007)

Revised: 12/2021

Document Id: d3f42cbc-0acd-0968-e053-2a95a90ad5bd

Set id: d1e9e9d3-99ae-86b1-e053-2995a90a136a

Version: 4

Effective Time: 20211225

Meixin Beauty & Health Care Products Co., Ltd.

78565-007 Zinc soap