Instant Hand Sanitizer

Instant Hand Sanitizer

Drug Labeling and Warnings

Drug Details

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INSTANT HAND SANITIZER- alcohol gel 
Hydrox Laboratories

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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Instant Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

  • hand sanitizer to help reduce bacteria on the skin that could cause disease

Warnings

Flammable. Keep away from fire or flame

For external use only - hands.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a physician if skin irritation or rash develops.

Keep out of reach of children. If accidently ingested, seek medical help or contact a Poison Control Center immediately.

Directions

  • place enough product in your palm to thoroughly cover your hands
  • rub hands together briskly until dry
  • children under 6 years of age should be supervised when using this product

Other Information

  • store at normal room temperature
  • may discolor certain fabrics
  • may be harmful to wood finishes and plastics

Inactive ingredients

carbomer, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, purified water, tocopheryl acetate, aloe vera gel, AMP-95

MFG BY: HYDROX LABORATORIES
825 Tollgate Road ELGIN, IL 60123

PRINCIPAL DISPLAY PANEL 

NDC: 10565-076-02

Hydrox
Laboratories

INSTANT
HAND
SANITIZER
with moisturizers
aloe & vitamin E

KILLS 99.9%
OF GERMS*

2 FL OZ 59 mL

Made in USA

Principal Display Panel - 59 mL Cylinder Label

INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10565-076
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
Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Alcohol (UNII: ND2M416302)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Aminomethylpropanol (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10565-076-0259 mL in 1 CYLINDER; Type 0: Not a Combination Product01/09/2012
2NDC: 10565-076-04118 mL in 1 CYLINDER; Type 0: Not a Combination Product01/09/2012
3NDC: 10565-076-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/09/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A01/09/2012
Labeler - Hydrox Laboratories (025164302)
Registrant - Hydrox Laboratories (025164302)
Establishment
NameAddressID/FEIBusiness Operations
Hydrox Laboratories025164302MANUFACTURE(10565-076) , label(10565-076) , pack(10565-076)

Revised: 3/2020
 
Hydrox Laboratories


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