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

Manufacturer: SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD
Effective date: 2020-06-13
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:17:37

Label at a glance#

ProductFocan LLC AFFEX CARE Hand Sanitizer(AC01-04-01)

Active ingredientALCOHOL

Label structure12 sections

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C(104F)

Label contents#

Full prescribing information#

active ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol :62% v/v. Purpose: Antiseptic

Antiseptic

OTC - PURPOSE SECTION

hand sanitizer

use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do note use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Direction

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

74913-500-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1305100	ethanol 75 % Topical Gel	PSN	4
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	4
1305100	ethanol 75 % Topical Gel	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
74913-555-02	2022-01-28	C162847	48780-1	d6a99b39-8f08-a426-e053-dadaa90af4c2	Focan LLC Affex Care Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
74913-555-02	Focan LLC AFFEX CARE Hand Sanitizer(AC01-04-01)	4000 mL in 1 BOTTLE, PLASTIC	GEL	4000		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
74913-555	FOCAN LLC AFFEX CARE HAND SANITIZER(AC01-04-01) (ALCOHOL) GEL [SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD]	4	Legacy NDC, 1 package rows	20200614_a803cbfc-b65e-00e3-e053-2995a90a38ab.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Focan LLC AFFEX CARE Hand Sanitizer(AC01-04-01)
Alcohol
PEG-40 CASTOR OIL
CARBOMER 940
WATER
TOCOPHEROL
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
74913-555	74913-555-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PEG-40 CASTOR OIL	4ERD2076EF	IACT
CARBOMER 940	4Q93RCW27E	IACT
WATER	059QF0KO0R	IACT
TOCOPHEROL	R0ZB2556P8	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
ALCOHOL	3K9958V90M	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a803dd63-802d-2490-e053-2a95a90acbcc			a803cbfc-b65e-00e3-e053-2995a90a38ab	2020-06-13	Warnings	Exact identifier spl id: a803dd63-802d-2490-e053-2a95a90acbcc spl set id: a803cbfc-b65e-00e3-e053-2995a90a38ab

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.