Label: 70% BIOKEN HAND SANITIZER WITH ALOE- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71331-107-01 - Packager: Orange Lab
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 1, 2022
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- 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
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INGREDIENTS AND APPEARANCE
70% BIOKEN HAND SANITIZER WITH ALOE
ethyl alcohol gelProduct 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 not final part333A 06/01/2020 Labeler - Orange Lab (004862271) Registrant - Orange Lab (004862271) Establishment Name Address ID/FEI Business Operations Orange Lab 004862271 manufacture(71331-107)
