Bothinns Hand Sanitizer Gel

Bothinns Hand Sanitizer Gel by

Drug Labeling and Warnings

Bothinns Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by CarrollCLEAN LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOTHINNS HAND SANITIZER GEL- alcohol gel 
CarrollCLEAN 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.

----------

Bothinns Hand Sanitizer Gel

Active Ingredients

Ethyl Alcohol 62% v/v..........................Antiseptic

Purpose

Antiseptic

Uses

To sanitize hands without requiring water or a rinse. Kills 99.9% of most common bacteria in 15 seconds.

Warnings

FLAMMABLE. For external use only.

When using this product

Do not use in or near the heat or flame. Do not use in or near eyes. Discontinue use if irritation and redness develop. Do not use on deep or puncture wounds, consult your doctor.

Keep out of reach of children.

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

Apply gel liberally to unsoiled hands and rub in thoroughly. Allow to dry without wiping or rinsing.

Other Information

Store at room temperature.

Inactive ingredients

Water, carbomer, glycerin, diisopropylamine, isopropyl myristate

Label

BOTHINNS HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73708-915
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.103 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.141 mL  in 100 mL
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)	1.822 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	34.434 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73708-915-14	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/26/2021

Labeler - CarrollCLEAN LLC (081222623)

Establishment
Name	Address	ID/FEI	Business Operations
CarrollCLEAN LLC		081222623	manufacture(73708-915)

Revised: 2/2021

Document Id: bc45cabb-656b-8f67-e053-2995a90ab971

34390-5

Set id: bc45cabb-656a-8f67-e053-2995a90ab971

Version: 1

Effective Time: 20210226