HAND SANITIZER- hand sanitizer gel 
GUANGZHOU XUELEI COSMETIC 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.

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HAND SANITIZER 74% Alcohol

ACTIVE INGREDIENTS

ETHYL ALCOHOL 74%

PURPOSE

ANTISEPTIC

USES

HELPS REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROMFIRE OR FLAME. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

STOP USE AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS, OR IF CONDITION PERSISTS FOR MORE THAN

72 HOURS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DISPENSE ONE PUMP OF SANITIZER ONTO HANDS AND RUB TOGETHER UNTIL DRY. USE AS NEEDED. FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION.

NOT RECOMMENDED FOR INFANTS.

OTHER INFO

STORE BELOW 110 (DEGREES FAHRENHEIT). MAY CAUSE DISCOLORATION TO CERTAIN FABRICS AND SURFACES.

INACTIVE INGREDIENTS

WATER ,CARBOMER , TRIETHANOLAMINE

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Package Label

HAND SANITIZER (30ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

30ml e (1.0 fl.oz.)

NDC: 74658-002-01 30ml label

Package Label

HAND SANITIZER (60ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

60ml e (2.0 fl.oz.)

NDC: 74658-002-02 60ml label 160ml label2

Package Label

HAND SANITIZER (60ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

60ml e (2.0 fl.oz.)

NDC: 74658-002-03 60ml Tube Label

Package Label

HAND SANITIZER (70ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

70ml e (2.36 fl.oz.)

NDC: 74658-002-04 70ml label

Package Label

HAND SANITIZER (100ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

100ml e (3.4 fl.oz.)

NDC: 74658-002-05 100ml label 1100ml label 2

Package Label

HAND SANITIZER (120ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

120ml e (4.0 fl.oz.)

NDC: 74658-002-06 120ml label

Package Label

HAND SANITIZER (236ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

236ml e (8 fl.oz.)

NDC: 74658-002-07 236ml label

Package Label

HAND SANITIZER (250ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

250ml e (8.5 fl.oz.)

NDC: 74658-002-08 250ml label

Package Label

HAND SANITIZER (260ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

260ml e (8.8 fl.oz.)

NDC: 74658-002-09 260ml label

Package Label

HAND SANITIZER (290ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

290ml e (9.8 fl.oz.)

NDC: 74658-002-10 290ml label

Package Label

HAND SANITIZER (300ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

300ml e (10.2 fl.oz.)

NDC: 74658-002-11 300ml label

Package Label

500ml e (17 fl.oz.)

NDC: 74658-002-12

500ml label

Package Label

HAND SANITIZER (950ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

950ml e (32.3 fl.oz.)

NDC: 74658-002-13 950ml label

Package Label

HAND SANITIZER (1000ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

1000ml e (34 fl.oz.)

NDC: 74658-002-14 1000ml label

Package Label

HAND SANITIZER (2000ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

2000ml e (68 fl.oz.)

NDC: 74658-002-15 2000ml label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74658-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL74 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) 0.4 g  in 100 mL
WATER (UNII: 059QF0KO0R) 23.5 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.22 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74658-002-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
2NDC:74658-002-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
3NDC:74658-002-0360 mL in 1 TUBE; Type 0: Not a Combination Product03/18/2020
4NDC:74658-002-0470 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
5NDC:74658-002-05100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
6NDC:74658-002-06120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
7NDC:74658-002-07236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
8NDC:74658-002-08250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
9NDC:74658-002-09260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
10NDC:74658-002-10290 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
11NDC:74658-002-11300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
12NDC:74658-002-12500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
13NDC:74658-002-13950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
14NDC:74658-002-141000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
15NDC:74658-002-152000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/18/2020
Labeler - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
Registrant - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)
Establishment
NameAddressID/FEIBusiness Operations
GUANGZHOU XUELEI COSMETIC CO.,LTD.526885026manufacture(74658-002) , pack(74658-002) , label(74658-002)

Revised: 11/2021
Document Id: d001741b-9d60-73f7-e053-2995a90a6a34
Set id: a2e5db51-082b-1fc9-e053-2995a90aa6be
Version: 4
Effective Time: 20211104
 
GUANGZHOU XUELEI COSMETIC CO.,LTD.