HAND SANITIZER gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Shantou Wanli Biotechnology Co.,Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antimicrobial 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:
OTC monograph not final
Authorization number:
74928-005-01

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HAND SANITIZER- hand sanitizer gel

Shantou Wanli Biotechnology 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.

----------

74928-005

Hand sanitizer

Active Ingredient(s)

Ethyl Alchohol 75%

Purpos e

Antimicrobial

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. Flammable. Keep away from heat or flame

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 15-30°C (59-86F)

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

Inactive ingredients

water/Aqua/Eau,Glycerin,Carbomer,Triethanolamine. Fragrance,Denatonium benzoate

Package Label - Principal Display Panel

74928-005-01 28ml

HAND SANITIZER

hand sanitizer gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:749 28 -0 0 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

75 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER 13 4 2 (UNII: 8 0 9 Y72KV36 )

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

DENATO NIUM BENZO ATE (UNII: 4YK5Z54AT2)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

FRAGRANCE LAVENDER & CHIA F-153 4 8 0 (UNII: SXS9 CO2TZK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:749 28 -0 0 5-0 1

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

0 4/13/20 20

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 4/13/20 20

Shantou Wanli Biotechnology Co.,Ltd.

Labeler -

Shantou Wanli Biotechnology Co.,Ltd. (544468822)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Shanto u Wanli Bio techno lo gy Co .,Ltd.

54446 8 8 22

ma nufa c ture (749 28 -0 0 5)

Revised: 12/2020

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