HAND SANITIZER- ddab liquid

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

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Active ingredient:
DIDECYLDIMONIUM BROMIDE (UNII: 72L098XL5Y) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)
Available from:
Bellwishes Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic, Hand Sanitizer Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Authorization status:
unapproved drug other
Authorization number:
80018-101-01, 80018-101-02, 80018-101-03

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HAND SANITIZER- ddab liquid

Bellwishes Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredient(s)

DIDECYLDIMONIUM BROMIDE 0.1%, Purpose: Antiseptic

Purpos e

Antiseptic, Hand Sanitizer

Us e

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water

are not available.

Warnings

For external use only.

Do not use

in children less than 2 months of age

on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes

thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

leuconostoc/radish root ferment, loureirin B, purified water USP

Package Label - Principal Display Panel

60 ml NDC: 80018-101-01

300 ml NDC: 80018-101-02

300 ml refill NDC: 80018-101-03

HAND SANITIZER

ddab liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 0 0 18 -10 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIDECYLDIMO NIUM BRO MIDE (UNII: 72L0 9 8 XL5Y) (DIDECYLDIMONIUM -

UNII:Z7F472XQPA)

DIDECYLDIMONIUM

BROMIDE

0 .1 g

in 10 0 mL

Inactive Ingredients

Bellwishes Corporation

Ingredient Name

Stre ng th

LO UREIRIN B (UNII: P47L6 9 79 8 O)

LEUCO NO STO C/RADISH RO O T FERMENT FILTRATE (UNII: D2QHA0 3458 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:8 0 0 18 -10 1-0 1

6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/30 /20 20

2

NDC:8 0 0 18 -10 1-0 2

30 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/30 /20 20

3

NDC:8 0 0 18 -10 1-0 3

30 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/30 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 3/0 1/20 20

Labeler -

Bellwishes Corporation (657457541)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bellwishes Co rpo ratio n

6 57457541

ma nufa c ture (8 0 0 18 -10 1)

Revised: 2/2021

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