RxNorm Names

Review RxNorm Normal Forms

XTRACARE INSTANT HAND SANITIZER (alcohol) spray
[Rejoice International]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1f1d7d81-3b5c-4db7-98f6-6501cd72b0d0

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE: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 Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

XtraCare instant Hand Sanitizer Spray

Active ingredient

Ethyl Alcohol 62%

Purpose

Antimicrobial

Uses

hand sanitizer to help reduce bacteria on the skin that may cause disease.
recommended for repeated use

Warnings

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

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin.

Stop use and ask a doctor if

irritation or rash appears and lasts.

Keep out of reach of children.

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

Directions

spray 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
not recommended for infants

Other Information

store below 1050F (400C)
may discolor certain fabrics or surfaces
harmful to wood finishes and plastics

Inactive ingredients

Water, Glycerin, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, FDandC Blue No. 1, FDandC Yellow No. 5.

XtraCare

instant Hand Sanitizer Spray Kills 99.9% of Germs Instantly

Use anywhere without the need for water
100+sprays per bottle

DISTRIBUTED BY: REJOICE INTERNATIONAL INC. 48325 BINGHAMPTON DR, NOTRHVILLE, MI 48168, USA
MADE IN CHINA.

XtraCare instant Hand Sanitizer Spray 2 PK 100+SPRAYS Kills 99.9% of Germs Instantly Leaves hands feeling soft with Aloe and Vitamin E Convenient Size for Purse, Pocket or Car PERFECT FOR TRAVEL 2x0.34 fl oz(2x10 ml)

Product Labels

Spray 10 ml Spray 2 Pack

XTRACARE INSTANT HAND SANITIZER
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57337-001
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
GLYCERIN
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5

Packaging
#	Item Code	Package Description
1	NDC:57337-001-02	2 in 1 PACKAGE
1	NDC:57337-001-00	10 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	02/08/2013

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Unichem		528196956	manufacture(57337-001)

Revised: 02/2013

Document Id: 37a8e424-f63f-4cc9-bca4-c5ccf681a9dc

Set id: 1f1d7d81-3b5c-4db7-98f6-6501cd72b0d0

Version: 1

Effective Time: 20130228

Rejoice International

Daily Med

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