All Safe Hand Sanitizer by Hunter Amenities International Limited / AMENI GROUP S A S All Safe Hand Sanitizer

All Safe Hand Sanitizer by

Drug Labeling and Warnings

All Safe Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Hunter Amenities International Limited, AMENI GROUP S A S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALL SAFE HAND SANITIZER- alcohol gel 
Hunter Amenities International Limited

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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All Safe Hand Sanitizer

Drug Facts

Active ingredient (v/v)

Ethyl Alcohol 70.0%

Purpose

Antiseptic skin cleanser

Uses

• Antiseptic (skin) cleanser
• Medicated (skin) cleanser
• Antibacterial (skin) cleanser
• Kills harmful bacteria/germs
• Effective in destroying (harmful) bacteria to provide antiseptic cleansing
• For personal hand hygiene to help prevent the spread of bacteria

Warnings

For external use only.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop us and ask/ consutl a doctor/ 

physician/ health care practitioner/ health care provider/ health care professional if irritation develops.

Keep out of reach of children.

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

Flammability warning. Keep away from open flame and soruces of heat.

Directions

• Adults and children over 2 years;
• For occasional and personal domestic use.
• Supervise children when they use this product.
• Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Inactive ingredients

Aqua/Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Parfum (Fragrance), Aloe Barbadensis Leaf Extract, Avena Sativa Kernal Extract, PEG-40 Hydrogenated Castor Oil, Tocopherol Acetate.

Questions?

1-800-668-1483

Package Labeling:30ml

Package Labeling:500ml

ALL SAFE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65910-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65910-009-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	06/30/2022
2	NDC: 65910-009-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	06/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/01/2020	06/30/2022

Labeler - Hunter Amenities International Limited (244071015)

Establishment
Name	Address	ID/FEI	Business Operations
AMENI GROUP S A S		885162108	manufacture(65910-009)

Revised: 10/2021

Document Id: cdb0be2c-2a0d-ab6c-e053-2995a90a84e9

34390-5

Set id: 22afa29f-2625-4fdf-b8cf-13d099e7860e

Version: 4

Effective Time: 20211006