on-the-spot HAND SANITIZER SPRAY Original

on-the-spot HAND SANITIZER Original by

Drug Labeling and Warnings

on-the-spot HAND SANITIZER Original by is a Otc medication manufactured, distributed, or labeled by On The Spot Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ON-THE-SPOT HAND SANITIZER ORIGINAL- hand sanitizer spray original spray 
On The Spot Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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on-the-spot HAND SANITIZER SPRAY Original

Active ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame. Do no use: on children less than 2 months of age on open skin wounds. When in use: keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

Do no use: on children less than 2 months of age on open skin wounds.

When in use: keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Place enough product on hands to cover all surfaces. Rub hand together until dry. Supervise children under age 6 when using this product to avoid swallowing.

Other Information

May discolor fabrics or surfaces. Avoid excessive heat. Store below 105℉(40℃).

Inactive Ingredients

Water(Aqua), BHT, Denatonium Benzoate, Tert-Butyl Alohol.

60ml, NDC: 77490-078-01

100ml, NDC: 77490-078-02

235ml, NDC: 77490-078-03

ON-THE-SPOT HAND SANITIZER ORIGINAL 
hand sanitizer spray original spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77490-078(NDC: 74658-014)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
WATER (UNII: 059QF0KO0R)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77490-078-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020
2	NDC: 77490-078-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020
3	NDC: 77490-078-03	235 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/21/2020	12/24/2020

Labeler - On The Spot Products, LLC (117497833)

Revised: 12/2020

Document Id: b75469cb-db88-d9cb-e053-2a95a90a0a6a

34390-5

Set id: b72beb04-1deb-18ce-e053-2995a90ac843

Version: 2

Effective Time: 20201225