OTC Medication Information: XtraCare Instant Hand Sanitizer Original

XTRACARE INSTANT HAND SANITIZER ORIGINAL — alcohol liquid
Rejoice International

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.

XtraCare instant Hand Sanitizer Original

Active ingredient:

Ethyl Alcohol 62.0%

Purpose

Antimicrobial

USE:

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

Warnings:

for external use only.
Flammable. Keep away from heat and flame.

When using this product

  • avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

Stop use and ask a doctor if

  • irritation or redness develops.

Keep out of reach of children.

if swallowed, get medical help or contact a Poison Control Center.

Directions

  • wet hands thoroughly with product and rub into skin until dry.
  • children under 6 years of age should be supervised by an adult when using.

Other Information:

  • store at 200 C to 250 C (680 to 770 F)
  • may discolor certain fabrics.

Inactive ingredients:

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, tocopheryl acetate (Vitamin E).

XtraCare

Hook it to your backpack, key chain, sports bag, purse, or anywhere you want the hand sanitizer!
DISTRIBUTED BY: REJOICE INTERNATIONAL INC. 48325 BINGHAMPTON DR, NOTRHVILLE, MI 48168, USA
MADE IN CHINA.

XtraCare instant Hand Sanitizer Original Kills 99.9% of Germs Instantly 2PK 2 X 1.8 FL OZ (53 ml) TOTAL 3.6 FL OZ (106 mL)

Product Labels

Original 53 ml
(click image for full-size original)
Original 2 Pack
(click image for full-size original)

XTRACARE INSTANT HAND SANITIZER ORIGINAL
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TROLAMINE
GLYCERIN
PROPYLENE GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57337-000-02 2 BOTTLE (BOTTLE) in 1 PACKAGE contains a BOTTLE (57337-000-00)
1 NDC:57337-000-00 53 mL in 1 BOTTLE This package is contained within the PACKAGE (57337-000-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333E 02/07/2013
Labeler — Rejoice International (078741245)
Establishment
Name Address ID/FEI Operations
Ningbo Unichem 528196956 manufacture (57337-000)

Revised: 02/2013 Rejoice International

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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