XtraCare Warm Vanilla

XTRACARE WARM VANILLA- ethyl alcohol gel
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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Active Ingredient Purpose

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

Uses

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

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

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

Directions

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

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 Ingredients

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

label image

XTRACARE WARM VANILLA
ethyl alcohol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Rejoice International (078741245)

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