Xtracare Instand Hand Sanitizer (Ethyl Alcohol) Liquid [China Ningbo Shangge Cosmetic Technology Corp.] -

XTRACARE INSTAND HAND SANITIZER (ETHYL ALCOHOL) LIQUID [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]
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NDC	58503-090-01
Set ID	4d75fcbc-7fcf-6884-e054-00144ff8d46c
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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PURPOSE

PURPOSE

Antimicrobial
ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 70%
INDICATIONS & USAGE

USAGE

For handwashing to decrease bacteria on the skin. Recommended for repeated use
DOSAGE & ADMINISTRATION

Directions

Wet hands thoroughly with product

Briskly rub hands together until dry

supervise children under six years in the use of this product
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.

Avoid contact with eyes. If this occurs, flush thoroughly with water.
WARNINGS

Warnings

For external use only

Flammable keep away from heat and flame

Do not use in the eye. in case of contact rinse thoroughly with water.

Stop use and ask doctor if irritation and redness develops and persist for more than 72 hours
INACTIVE INGREDIENT

WATER, CARBOMER, TOCOPHEROL ACETATE, PROPYLENE GLYCOL, ALOE BARBADENSIS LEAF JUICE, TRIETHANOLAMINE, GLYCERIN
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE INSTAND HAND SANITIZER
ethyl alcohol liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58503-090-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/18/2017

Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(58503-090)

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Medic