HYDRATING INSTANT HAND SANITIZER- alcohol gel

Hydrating Instant Hand Sanitizer by

Drug Labeling and Warnings

Hydrating Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Micrylium Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70 percent

Purpose

Antimicrobial

Uses

Cleansing gel for hands that need frequent care.

Decrease bacteria on skin.

Warnings

For external use only.

Flammable, keep away from fire or flame.

DO NOT USE

Do not use in or near the eyes, in case of exposure rinse eyes throughly with water.

Do not use if you have preexisting rash condition.

STOP USE

Stop use and ask a doctor if irritation, redness or rash appear.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away.

Directions

Apply approximately 3ml on palm and rub hands for 30 seconds.

Rinsing is not required.

Inactive Ingredients

aloe barbadensis, aroma, blue 1 (CI 42090), carbomer, cetyl alcohol, glycerin, panthenol, tocopherol acetate, triethanolamine, water, yellow 5 (CI 19140)

PRINCIPAL DISPLAY PANEL

Drug Facts

INGREDIENTS AND APPEARANCE

HYDRATING INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59371-6510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	42 mL  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA FLOWER (UNII: 575DY8C1ER)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59371-6510-0	60 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/01/2013

Labeler - Micrylium Laboratories (252529185)

Registrant - Micrylium Laboratories (252529185)

Establishment
Name	Address	ID/FEI	Business Operations
Micrylium Laboratories		252529185	manufacture(59371-6510) , pack(59371-6510) , label(59371-6510)