OTC Medication Information: Justice Vanilla Scented Anti-bacterial Hand Sanitizer

JUSTICE VANILLA SCENTED ANTI-BACTERIAL HAND SANITIZER- alcohol gel
TWEEN BRANDS, INC

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 Facts

Active ingredient

Alcohol 62%

Purpose

Antiseptic

Use

  • For hand washing to decrease bacteria on the skin.
  • Recommended for repeated use.

Warnings

Flammable, keep away from fire or flame.

For external use only.

Do not use

in the eyes the eyes or apply the eyes or apply over large areas of the body.

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Use only as directed. Do not drink. If taken internally, it will produce serious gastric disturbances.

Stop use and ask a doctor if

Irritation 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

  • Wet hands thoroughly with product and allow to dry without wiping.
  • Supervise children in the use of this product.

Other information

  • Store below 105°F (40.5°C).
  • May discolor some fabrics.

Expiry Date: 03/2023

Inactive ingredients

Water, Glycerin, Propylene Glycol, Fragrance,/Parfum, Carbomer, Triethanolamine, Mica

Package Labeling:

Label
(click image for full-size original)
Label2
(click image for full-size original)

JUSTICE VANILLA SCENTED ANTI-BACTERIAL HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60637-227
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 620 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
CARBOXYPOLYMETHYLENE
TROLAMINE
MICA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60637-227-30 30 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/20/2019
Labeler — TWEEN BRANDS, INC (965758188)

Revised: 11/2019 TWEEN BRANDS, INC

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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