Xtracare Cucumber Melon (Ethyl Alcohol) Gel [China Ningbo Shangge Cosmetic Technology Corp] -

XTRACARE CUCUMBER MELON (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]
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NDC	58503-071-01
Set ID	a3eaec52-0ed9-4cc7-a98c-fc68eb63094b
Category	HUMAN OTC DRUG LABEL
Packager	China Ningbo Shangge Cosmetic Technology Corp
Generic Name
Product Class
Product Number
Application Number	PART333E

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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 blue no. 1, fd&c yellow no.5
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE CUCUMBER MELON
ethyl alcohol gel

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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58503-071-01	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 - China Ningbo Shangge Cosmetic Technology Corp (529287434)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(58503-071)

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