XTRACARE INSTANT HAND SANITIZER - alcohol spray 
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.

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XtraCare instant Hand Sanitizer Spray

XtraCare instant Hand Sanitizer Spray


Active ingredient

Ethyl Alcohol 62%

Purpose

Antimicrobial

Uses

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

Other Information

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

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 mlSpray 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 (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)

Revised: 2/2013
Document Id: 37a8e424-f63f-4cc9-bca4-c5ccf681a9dc
Set id: 1f1d7d81-3b5c-4db7-98f6-6501cd72b0d0
Version: 1
Effective Time: 20130228
 
Rejoice International