Bioken Hand Sanitizer with Aloe 70% 16oz

70% Bioken Hand Sanitizer with aloe by

Drug Labeling and Warnings

70% Bioken Hand Sanitizer with aloe by is a Otc medication manufactured, distributed, or labeled by Orange Lab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

70% BIOKEN HAND SANITIZER WITH ALOE- ethyl alcohol gel 
Orange Lab

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Bioken Hand Sanitizer with Aloe 70% 16oz

Active Ingredient

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children.

Purpose : Antiseptic

Questions ?

Stop use and ask a doctor if skin irritation develops.

When using this product section

Directions section

Other safety information

Inactive ingredients

Warnings section

Dosage & Administration section

Indications & Usage section

Package front label

70% BIOKEN HAND SANITIZER WITH ALOE 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71331-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	4 mL  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z)	0.5 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)	0.3 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	25.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71331-107-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/01/2020	07/01/2024

Labeler - Orange Lab (004862271)

Registrant - Orange Lab (004862271)

Establishment
Name	Address	ID/FEI	Business Operations
Orange Lab		004862271	manufacture(71331-107)

Revised: 4/2026

Document Id: 4f10aac7-8818-4edb-e063-6394a90a6016

34390-5

Set id: a72127ab-8a87-3f09-e053-2995a90ae4f6

Version: 4

Effective Time: 20260409

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