BURT'S BEES NATURALLY CLEAN HAND SANITIZER W/ WITCH HAZEL

BURTS BEES Naturally Clean Hand Sanitizer by

Drug Labeling and Warnings

BURTS BEES Naturally Clean Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by BURT's BEES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BURTS BEES NATURALLY CLEAN HAND SANITIZER- alcohol solution 
BURT's BEES, INC

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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BURT'S BEES NATURALLY CLEAN HAND SANITIZER W/ WITCH HAZEL

Active Ingredient(s)

Ethyl Alcohol 66% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For hand washing to decrease bacteria on the skin when water is not available.

Warnings

For external use only. Flammable. Keep away from heat and open flame.

Do not use

• in or near eyes
• in children less than 2 months of age
• on deep puncture woulds; consult your doctor

When using this product Do not use in or near eyes.

Disconinue use if irritaiton and redness develop

Do not use on deep puncture woulds: consult your doctor

Stop use if irritation or rash occurs.

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

Directions

• Apply liberally to unsoiled hands and rub thoroughly
• Allow to dry witihout wiping or rinsing

Other information

Stoer at room temperature

Inactive ingredients

glycerin, hamamelis virginiana(witch hazel) water, purified water USP

Package Label - Principal Display Panel

BURTS BEES NATURALLY CLEAN HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26052-423
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	66 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 L  in 100 mL
WITCH HAZEL (UNII: 101I4J0U34)	0.125 L  in 100 mL
WATER (UNII: 059QF0KO0R)	18.425 L  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-423-01	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/31/2020	03/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/31/2020	03/31/2023

Labeler - BURT's BEES, INC (613480946)

Revised: 6/2023

Document Id: fe1b8b23-8e0f-14a8-e053-6394a90ab374

34390-5

Set id: 1f29707a-f97e-4779-b568-9aaecfa3e1e0

Version: 7

Effective Time: 20230614