Hand Sanitizer by Point One International, Ltd. / Northmed SIA RPPE Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Point One International, Ltd., Northmed SIA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- benzalkonium chloride spray 
Point One International, 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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RPPE Hand Sanitizer

Benzalkonium Chloride (.20%). Purpose: Antiseptic

Antiseptic. Hand Sanitizer.

Sanitizer to help reduce bacteria on hands. Recommended for repeated use.

For external use only.

Should not be sotred below 41F/5C or above 104F/40C.

Do not use in or near eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

Stop use and ask a doctor if irritation and rendess develop and persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison control center immediately.

Apply to hands and rub into the surface of the hands until completely absorbed.

Water, Glycerin, Panthenol, Aloe Vera, Tetrasodium Glutamate Diacetate.

33.8 fl. oz. 1000ml. NDC: 78522-104-00

2 fl. oz. 59ml. NDC: 78522-100-00

HAND SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81207-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	2 mg  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81207-011-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/05/2021
2	NDC: 81207-011-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/05/2021	01/05/2021

Labeler - Point One International, Ltd. (150340206)

Establishment
Name	Address	ID/FEI	Business Operations
Point One International, Ltd.		150340206	pack(81207-011) , label(81207-011)

Establishment
Name	Address	ID/FEI	Business Operations
Northmed SIA		662588132	manufacture(81207-011)

Revised: 7/2022

Document Id: e34c9bb4-1483-c99f-e053-2a95a90a4ff4

34390-5

Set id: bd9fe98c-6f10-f1c7-e053-2a95a90a3ba2

Version: 4

Effective Time: 20220708