ASSURED INSTANT HAND SANITIZER ALOE- ethyl alcohol gel

Assured Instant Hand Sanitizer Aloe by

Drug Labeling and Warnings

Assured Instant Hand Sanitizer Aloe by is a Otc medication manufactured, distributed, or labeled by China Ningbo Shangge Cosmetic Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Assured

Instant Hand Sanitizer

Kills 99% of germs!

Aloe Vera & Moisturizers

Compare to Active Ingredients in Purell® Hand Sanitizer*

Special Value 25% more free

11.2 fl oz / 331 ml

*This product is not manufactured or distributed by Gojo Industries Inc, distributor of the registered trademark Purell

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

ASSURED INSTANT HAND SANITIZER ALOE 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58503-113
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58503-113-01	331 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/01/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(58503-113)