ASSURED ALOE- ethyl alcohol gel

Assured Aloe by

Drug Labeling and Warnings

Assured Aloe by is a Otc medication manufactured, distributed, or labeled by 4E Global, S.A.P.I. de C.V. 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

Kills 99% of germs!

Aloe Vera & Moisturizers

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.

Product Label

INGREDIENTS AND APPEARANCE

ASSURED ALOE 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60599-999
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: 60599-999-10	295 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/27/2017

Labeler - 4E Global, S.A.P.I. de C.V (812821307)

Establishment
Name	Address	ID/FEI	Business Operations
4E Global, S.A.P.I. de C.V		812821307	manufacture(60599-999)