on-the-spot SCENTED HAND SANITIZER Citrus

on-the-spot SCENTED HAND SANITIZER Citrus by

Drug Labeling and Warnings

on-the-spot SCENTED HAND SANITIZER Citrus 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 SCENTED HAND SANITIZER CITRUS- scented hand sanitizer citrus gel 
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 SCENTED HAND SANITIZER Citrus

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), Aminomethyl Propanol, Benzyl Alcohol, Benzyl Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citral, Citronellol, Denatonium Benzoate, Fragrance(Parfum), Geraniol, Hexyl Cinnamal, Limonene, Linalool, Tert-Butyl Alcohol.

236ml, NDC: 77490-083-01

500ml, NDC: 77490-083-02

5000ml, NDC: 77490-083-03

ON-THE-SPOT SCENTED HAND SANITIZER CITRUS 
scented hand sanitizer citrus gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77490-083
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL BENZOATE (UNII: N863NB338G)
CITRAL (UNII: T7EU0O9VPP)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
CITRUS FRUIT (UNII: XDK00Z8012)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77490-083-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020
2	NDC: 77490-083-02	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/21/2020
3	NDC: 77490-083-03	5000 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	12/31/2022

Labeler - On The Spot Products, LLC (117497833)

Revised: 1/2023

Document Id: f29ad352-6ffa-711b-e053-2a95a90aabc6

34390-5

Set id: b77cba36-027b-808a-e053-2995a90aac1a

Version: 3

Effective Time: 20230119