XTRACARE INSTANT HAND SANITIZER- alcohol spray

XtraCare instant Hand Sanitizer by

Drug Labeling and Warnings

XtraCare instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Rejoice International, Ningbo Unichem. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

XTRACARE INSTANT HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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)