SCENTED HAND SANITIZER Lavender

on-the-spot SCENTED HAND SANITIZER Lavender by

Drug Labeling and Warnings

on-the-spot SCENTED HAND SANITIZER Lavender 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 LAVENDER- scented hand sanitizer 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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SCENTED HAND SANITIZER Lavender

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 not 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 not 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 hands 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), Fragrance (Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol,Tert-Butyl Alcohol, Denatonium Benzoate, Linalool, Geraniol, Limonene, Hexyl Cinnamal, Citronellol, Coumarin, Benzyl Benzoate, Amyl Cinnamal, Benzyl Salicylate, Citral, Eugenol, Benzyl Alcohol.

236ml NDC: 77490-077-01

236ml label

500ml NDC: 77490-077-02

500ml label

5000ml NDC: 77490-077-03

5L label

ON-THE-SPOT SCENTED HAND SANITIZER LAVENDER 
scented hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77490-077
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARYOPHYLLENE (UNII: BHW853AU9H) 0.0026 g  in 100 mL
CAMPHENE (UNII: G3VG94Z26E) 0.0026 g  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.11 g  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.08 g  in 100 mL
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) 0.000374 g  in 100 mL
WATER (UNII: 059QF0KO0R) 22.03 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) 0.013 g  in 100 mL
CEDROL (UNII: 63ZM9703BO) 0.0026 g  in 100 mL
EUCALYPTOL (UNII: RV6J6604TK) 0.0026 g  in 100 mL
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT) 0.0026 g  in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.35 g  in 100 mL
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.000914 g  in 100 mL
LINALYL ACETATE (UNII: 5K47SSQ51G) 0.026 g  in 100 mL
MUSK KETONE (UNII: 483V3E1L6J) 0.013 g  in 100 mL
LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.044841 g  in 100 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.002974 g  in 100 mL
COUMARIN (UNII: A4VZ22K1WT) 0.000803 g  in 100 mL
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) 0.000131 g  in 100 mL
BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.00013 g  in 100 mL
ACETYL HEXAMETHYL TETRALIN (UNII: 360Q8Z01IP) 0.0026 g  in 100 mL
GERANIOL (UNII: L837108USY) 0.003326 g  in 100 mL
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF) 0.000848 g  in 100 mL
BENZYL BENZOATE (UNII: N863NB338G) 0.000131 g  in 100 mL
CITRAL (UNII: T7EU0O9VPP) 0.00005 g  in 100 mL
EUGENOL (UNII: 3T8H1794QW) 0.000003 g  in 100 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) 0.000002 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77490-077-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
2NDC: 77490-077-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/22/2020
3NDC: 77490-077-035000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/22/202012/31/2022
Labeler - On The Spot Products, LLC (117497833)

Revised: 1/2023
Document Id: f2784d9c-3eef-c83a-e053-2995a90aa0dd
Set id: aff11cd4-fc4a-3217-e053-2a95a90a2719
Version: 7
Effective Time: 20230117