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

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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Bioken Hand Sanitizer with Aloe 70% 16oz

Active Ingredient

Active Ingredient

Stop use and ask a doctor if skin irritation develops.

Ask a doctor

Keep out of reach of children.

keep out of reach of children

Purpose : Antiseptic

Purpose

Questions ?

Questions

Stop use and ask a doctor if skin irritation develops.

Stop use

When using this product section

When using this product

Directions section

Directions

Other safety information

Other safety information

Inactive ingredients

Inactive ingredient

Warnings section

warnings

Dosage & Administration section

Dosage

Indications & Usage section

Indications and usage

Package front label

Front label

70% BIOKEN HAND SANITIZER WITH ALOE 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71331-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71331-107-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Orange Lab (004862271)
Registrant - Orange Lab (004862271)
Establishment
NameAddressID/FEIBusiness Operations
Orange Lab004862271manufacture(71331-107)

Revised: 2/2022
Document Id: d6f89a16-80e4-7bb8-e053-2995a90af293
Set id: a72127ab-8a87-3f09-e053-2995a90ae4f6
Version: 3
Effective Time: 20220201
 
Orange Lab