BETTER FOR DAILY USE EAAE DISINFECTANT- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

JIANGSU HANHE DAILY CHEMICALS CO., LTD.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antimicrobial Hand sanitizer to help reduce bacteria on the skin Stop use and ask a doctor if irritation or rash appears and lasts

Authorization status:

OTC monograph not final

Summary of Product characteristics

BETTER FOR DAILY USE EAAE DISINFECTANT- ALCOHOL GEL
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._
----------
Ethyl Alcohol 75% v/v
PURPOSE
Antimicrobial
USE
Hand sanitizer to help reduce bacteria on the skin
WARNINGS
For external use only.
Non Medical. Flammable. Keep away from fire or flame
When using this product, do not use in or near eyes, In case of
contact, rinse eyes
thoroughly with water
Stop use and ask a doctor if irritation or rash appears and lasts
Keep out of reach of children. If swallowed, get medical help or
contact a poison control
center right away
DIRECTIONS
Put enough product on your palm to cover hands and rub hands together
briskly
until dry
INACTIVE INGREDIENTS
Water, Carbomer, Triethanolamine, Glycerin
BETTER FOR DAILY USE EAAE DISINFECTANT
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73027-206
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
75 mL in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CARBOMER 934 (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:73027-206-
01
60 mL in 1 BOTTLE; Type 0: Not a Combination
Product
06/16/2020
JIANGSU HANHE DAILY CHEMICALS CO., LTD.
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333A
06/16/2020
LABELER -
JIANGSU HANHE DAILY CHEMICALS CO., LTD. (414409758)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
JIANGSU HANHE DAILY CHEMICALS CO., LTD.
414409758
manufacture(73027-206)
Revised: 11/2021