DEODORANT- benzethonium chloride soap

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

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Active ingredient:
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)
Available from:
JIANGSU HANHE DAILY CHEMICALS CO., LTD.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Antibacterial Uses: For washing to decrease bacteria on skin
Authorization status:
OTC monograph not final
Authorization number:
73027-001-01, 73027-001-02, 73027-001-03

DEODORANT- benzethonium chloride soap

JIANGSU HANHE DAILY CHEMICALS 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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Active Ingredient:

Benzethonium Chloride: 0.1%

Purpose:

Antibacterial

Uses:

For washing to decrease bacteria on skin

Warnings:

External use only

When using this product, avoid contact with eyes. In case of eye contact, fush with water.

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

Stop use and ask doctor if irritation and redness develop

Do not use this product on infants under age of 6

Keep out of reach of children.

Wet bar with water

Lather vigorously and wash skin

Rinse and dry thoroughly

Inactive Ingredients:

Soap (Sodium Palmate, and/or Sodium Tallowate, Sodium Cocoate, and/or Sodium Palm Kernelate),

Calcium Carbonate, Water, Glycerin, Sodium Chloride, Sodium Hydroxide, Fragrance, Tetrasodium

EDTA, Etidronate Tetrasodium

DEODORANT

benzethonium chloride soap

JIANGSU HANHE DAILY CHEMICALS CO., LTD.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 27-0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM -

UNII:1VU15B70 BP)

BENZETHONIUM

CHLORIDE

0 .0 9 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM PALMATE (UNII: S0 A6 0 0 4K3Z)

SO DIUM TALLO WATE, BEEF (UNII: 0 7RIK6 QMEW)

SO DIUM CO CO ATE (UNII: R1TQH25F4I)

SO DIUM PALM KERNELATE (UNII: 6 H9 1L1NXTW)

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

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

TRISO DIUM HEDTA (UNII: K3E0 U7O8 KI)

ETIDRO NATE TETRASO DIUM (UNII: CZZ9 T1T1X4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 27-0 0 1-0 1

12 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

0 4/15/20 19

2

NDC:730 27-0 0 1-0 2

32 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

0 4/15/20 19

3

NDC:730 27-0 0 1-0 3

8 2 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

0 4/15/20 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 no t final

pa rt333A

0 4/15/20 19

Labeler -

JIANGSU HANHE DAILY CHEMICALS CO., LT D. (414409758)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

JIANGSU HANHE DAILY CHEMICALS CO., LTD.

41440 9 758

ma nufa c ture (730 27-0 0 1)

Revised: 1/2020

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