INSTANT HAND SANITIZER ALOE VERA- ethyl alcohol liquid

Instant Hand Sanitizer Aloe Vera by

Drug Labeling and Warnings

Instant Hand Sanitizer Aloe Vera by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Ethyl alcohol  70% v/v

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Use

• Hand sanitizer to help reduce bacteria on the skin.

WARNINGS

Warnings

Flammable. Keep away from fire or flame.

For external use only.

WHEN USING

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts.

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

• Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry.
• Children under 6 years of age should be supervised when using this product.

SPL UNCLASSIFIED SECTION

Other information

• Store below 106°F (41°C).
• May discolor certain fabrics or surfaces.

INACTIVE INGREDIENT

Inactive ingredients

Water, glycerin, propylene glycol, acrylates/c10-30 alkyl acrylate crosspolymer, isopropyl alcohol, aminomethyl propanol,  isopropyl myristate,  caprylyl glycol, phenoxyethanol, fragrance, tocopheryl acetate, aloe barbadensis gel, FD&C yellow no.5, FD&C blue no.1.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INSTANT HAND SANITIZER ALOE VERA WITH VITAMIN E AND OTHER MOISTURIZERS

ANTIMICROBIAL

KILLS GERMS WITHOUT WATER

8 FL.OZ (236 mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER ALOE VERA 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-016
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)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-016-29	59 mL in 1 BOTTLE, PLASTIC
2	NDC: 52000-016-01	118 mL in 1 BOTTLE, PLASTIC
3	NDC: 52000-016-30	236 mL in 1 BOTTLE, PLASTIC
4	NDC: 52000-016-31	295 mL in 1 BOTTLE, PLASTIC
5	NDC: 52000-016-32	354 mL in 1 BOTTLE, PLASTIC
6	NDC: 52000-016-33	472 mL in 1 BOTTLE, PLASTIC
7	NDC: 52000-016-34	708 mL in 1 BOTTLE, PLASTIC
8	NDC: 52000-016-35	944 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	11/22/2014

Labeler - Universal Distribution Center LLC (019180459)