FOCAN LLC AFFEX CARE HAND SANITIZER(AC01-04-01)- alcohol gel

Focan LLC AFFEX CARE Hand Sanitizer(AC01-04-01) by

Drug Labeling and Warnings

Focan LLC AFFEX CARE Hand Sanitizer(AC01-04-01) by is a Otc medication manufactured, distributed, or labeled by SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredients

Alcohol :62% v/v. Purpose: Antiseptic

Antiseptic

hand sanitizer

use

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 note use

In children less than 2 months of age. On open skin wounds

WHEN USING

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

STOP USE

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

keep out of reach of children. If swalloed get medical help or contact a poison control center right away

Direction

Place enought 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

Water, Peg-40 Castor oil, Carbomer ,sodium hydroxide ,Tocopherol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOCAN LLC AFFEX CARE HAND SANITIZER(AC01-04-01) 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74913-555
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
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)	0.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	23.2 mL  in 100 mL
TOCOPHEROL (UNII: R0ZB2556P8)	0.5 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74913-555-02	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/10/2020

Labeler - SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD (546345856)

Registrant - SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD (546345856)

Establishment
Name	Address	ID/FEI	Business Operations
SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD		546345856	manufacture(74913-555)