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 consult a doctor if irritation or rash occurs

Authorization status:

OTC monograph not final

Summary of Product characteristics

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 consult a doctor if irritation or rash occurs
Keep out of reach of children. If swallowed, seek immmediate medical
help or contact a
poison control center
DIRECTIONS
Apply liberally to the hands and rub until dry
INACTIVE INGREDIENTS
Water, Carbomer, Triethanolamine, Glycerin, Perfume, Castor Oil,
Hydrogenated, Aloe
Vera Extract
JIANGSU HANHE DAILY CHEMICALS CO., LTD.
EAAE DISINFECTANT
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73027-204
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)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:73027-204-
01
60 mL in 1 TUBE; Type 0: Not a Combination
Product
05/30/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333A
05/30/2020
LABELER -
JIANGSU HANHE DAILY CHEMICALS CO., LTD. (414409758)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
JIANGSU HANHE DAILY CHEMICALS CO., LTD.
414409758
manufacture(73027-204)
Revised: 11/2021