OTC Medication Information: Juicey Hand Sanitizer

JUICEY HAND SANITIZER- alcohol gel
Fuson LLC

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 Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine, Aloebarbadensis Extract, Tocopheryl Acetate

Package Label — Principal Display Panel

100 ml NDC: 78141-900-01

250 ml NDC: 78141-900-02

500 ml NDC: 78141-900-03

1000 ml NDC: 78141-900-04

3780 ml NDC: 78141-900-05

500ml
(click image for full-size original)
JUICEY HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78141-900
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER 30 mL in 100 mL
CARBOMER 980 0.25 g in 100 mL
TROLAMINE 0.15 mL in 100 mL
GLYCERIN 1 mL in 100 mL
ALOE VERA LEAF 0.01 g in 100 mL
.ALPHA.-TOCOPHEROL ACETATE, D- 0.01 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78141-900-03 500 mL in 1 BOTTLE None
2 NDC:78141-900-01 100 mL in 1 BOTTLE None
3 NDC:78141-900-02 250 mL in 1 BOTTLE None
4 NDC:78141-900-04 1000 mL in 1 BOTTLE None
5 NDC:78141-900-05 3780 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/10/2020
Labeler — Fuson LLC (113376279)

Revised: 06/2020 Fuson LLC

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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