XTRACARE WARM VANILLA- ethyl alcohol gel

XtraCare Warm Vanilla by

Drug Labeling and Warnings

XtraCare Warm Vanilla by is a Otc medication manufactured, distributed, or labeled by Rejoice International, China Ningbo Shangge Cosmetic Technology Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                          Purpose

Ethyl Alcohol 62.0% ................. Antimicrobial

PURPOSE

Uses

• for handwashing to decrease bacteria on the skin
• recommended for repeated use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

INDICATIONS & USAGE

XtraCare®
Kills 99.9% of germs
Instant Hand Sanitizer
with moisturizers
cucumber melon scent
8 FL OZ / 237 mL

DOSAGE & ADMINISTRATION

Directions

• wet hands thoroughly with product
• briskly rub hands together until dry
• supervise children under 6 years in the use of this product

WARNINGS

Warnings

For external use only

Flammable, keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

INACTIVE INGREDIENT

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, fd&c red no.33

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE WARM VANILLA 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-074
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-074-01	237 g in 1 BOTTLE; Type 0: Not a Combination Product	02/17/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/17/2015

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(57337-074)