OTC Medication Information: ZYTEC GERM BUSTER HAND SANITIZER

ZYTEC GERM BUSTER HAND SANITIZER- ethanol aerosol, spray
Empack

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.

Active Ingredients

Ethyl Alcohol 80%

Purpose

Antiseptic

Uses

  • For handwashing to decrease bacteria on the skin
  • recommended for repeated use

Warnings

For external use only

Flammable, keep away from fire or flame.

Contents under pressure

Do not puncture of incinerate

Do not expose to heat or store at temperatures above 120o F / 50o C or in enclosed places that could overheat.

Do not use in or near eyes. In case of contact rinse eyes thoroughly with water.

Stop use and ask a doctor if, irritation and redness 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 right away.

Directions

  • spray in palm of hand ans rub over entire surface of hands
  • briskly rub hands together until dry
  • supervise children in the use of this product
  • spray product generously over hands, rub together until product drys.

Other Information

  • may discolor certain fabric

Inactive Ingredients

Water (aqua) , Isobutene, Fragrance,

MM2
product label
(click image for full-size original)
ZYTEC GERM BUSTER HAND SANITIZER
ethanol aerosol, spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50021-080
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHANOL (ETHANOL) ETHANOL 224 g in 400 g
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50021-080-08 35 g in 1 CAN None
2 NDC:50021-080-09 400 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 01/31/2011
Labeler — Empack (252047519)
Registrant — Empack (252047519)
Establishment
Name Address ID/FEI Operations
Empack 252047519 manufacture

Revised: 01/2011 Empack

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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