ASSURED INSTANT HAND SANITIZER LEMON 2 PK- ethyl alcohol gel

Assured Instant Hand Sanitizer Lemon by

Drug Labeling and Warnings

Assured Instant Hand Sanitizer Lemon 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

Ethyl Alcohol 70.0%

PURPOSE

Antimicrobial

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.

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

INDICATIONS & USAGE

Use:

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

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, tocopheryl acetate (Vitamin E), fd&c yellow no. 5.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED INSTANT HAND SANITIZER LEMON  2 PK
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58503-111
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
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58503-111-02	2 in 1 BOX	12/01/2018
1	NDC: 58503-111-01	59.2 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/21/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(58503-111)