BELUX LONDON HAND SANITIZER WITH ALOE VERA- alcohol gel 
Belux UK Medical Technology 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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Active Ingredient

Alcohol 75% (v/v)

1

Purpose

Antiseptic

2

Uses

To help decrease germs on the skin that could cause disease.

Recommended for repeated use.

3

Warnings

For external use only: hands

Flammable, keep away from fire or flame. 4

When using this product:

Avoid contact with broken skin.
Do not inhale or ingest.
Use with Caution if allergic.

5

When using this product:

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
Avoid contact with broken skin.
Do not inhale or ingest.
Use with Caution if allergic.

6

Stop use and ask a doctor if:

Irritation or redness develops.
Condition persists for more than 72 hours. 7

Keep out of reach by children:

If swallowed, get medical help or contact a Poison Control Center right away.

8

Directions

Wet hands thoroughly without wiping until they dry.
For children under 6, use only under adult supervision.

Not recommended for infants.

9

Other information

After use, seal and tighten the cap and use product within the validity period.
After use, seal and keep away from light and moisture.

Store in a cool and dry place. Do not store above 37℃ (98.6℉) 10

Inactive ingredients

Aloe, Carbomer 940, Glycerin, Trolamine, Water. 11

Package Label - Principal Display Panel

100 mL NDC: 77084-001-01

100 ml

300 mL NDC: 77084-001-02

300 ml

500 mL NDC: 77084-001-03

500 ml

BELUX LONDON HAND SANITIZER WITH ALOE VERA 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77084-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.55 mL  in 100 mL
ALOE (UNII: V5VD430YW9) 0.05 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 19 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 4 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77084-001-01100 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package06/15/2020
2NDC:77084-001-02300 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package06/15/2020
3NDC:77084-001-03500 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package06/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/2020
Labeler - Belux UK Medical Technology Ltd (225838376)
Registrant - Belux UK Medical Technology Ltd (225838376)
Establishment
NameAddressID/FEIBusiness Operations
Belux UK Medical Technology Ltd225838376repack(77084-001) , relabel(77084-001)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Junchen Cosmetics Co., Ltd.402958582manufacture(77084-001) , pack(77084-001) , label(77084-001)

Revised: 6/2020
Document Id: a7ff5d1d-43ba-5b29-e053-2995a90a9e92
Set id: a7ff5d1d-43bb-5b29-e053-2995a90a9e92
Version: 1
Effective Time: 20200615
 
Belux UK Medical Technology Ltd