SANELL HAND SANITIZER- alcohol gel

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. When using this product: keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and ask a doctor: if irritation and redness develop. Condition persists for more than 72 hours.

Directions

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Inactive Ingredients

Carbomer, DMDM Hydantoin, Fragrance, Isopropanol, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SANELL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-166
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	58.10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.010 mg  in 1 g
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)	.310 mg  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	.500 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63645-166-01	1 g in 1 CONTAINER; Type 0: Not a Combination Product	03/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/07/2018

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(63645-166) , LABEL(63645-166)