Hand Sanitizer Refill 15 Oz (Ethyl Alcohol) Gel [China Ningbo Shangge Cosmetic Technology Corp.] -

HAND SANITIZER REFILL 15 OZ (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]
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NDC	58503-105-01
Set ID	71d97cb6-f736-f2df-e053-2995a90ad5cf
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 70.0% v/v..................... 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

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 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

HAND SANITIZER REFILL 15 OZ
ethyl alcohol gel

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

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:58503-105-01	443 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/02/2018

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

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(58503-105)

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Medic