SANELL HAND SANITIZER- alcohol spray

Sanell Hand Sanitizer by

Drug Labeling and Warnings

Sanell Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 63.00%

Purpose

Antiseptic

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only: Hands. Flammable. Keep away from fire or 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 persists for more than 72 hours.

Directions

Wet hands thoroughly with product and allow to dry without wiping. Supervise children in the use of this product.

Inactive Ingredients

Dimethicone, Disodium EDTA, DMDM Hydantoin, Fragrance, Polysorbate 20, Propanediol, Water.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SANELL HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-167
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)	0.043 mL  in 1 mL
WATER (UNII: 059QF0KO0R)	56.205 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63645-167-01	1 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/12/2019

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(63645-167) , LABEL(63645-167)