HAND SANITIZER-CITRUS GARDEN- hand sanitizer gel gel
Burwell Industries, 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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Hand Sanitizer - Antibacterial Hand Sanitizer

Active ingredient

Alcohol 70%

Purpose

Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

Flammable, Keep away from fire or flame.

For External Use only.

When Using this product.

do not use in or near the eyes, in case of contact, rinse throughly with water.

Stop Using this product.

if irritation or rash appears and lasts.

Keep out of Reach of Children

if Swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product in your palm to throoughly cover your hands. Rub hands together briskly until dry.
Children under 6 years of age should be supervised when using this product.

Other information

Store below 110°F (43°C)

Ingredients

Alcohol, Water, Acrylates(C-10/30 Alkyl Acylate) Crosspolymer, Aloe Vera, Triethanolamine.

Package Label - Principal Disaplay Label

354 mL Label 354 mL NDC: 78109-070-03

HAND SANITIZER-CITRUS GARDEN
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78109-070
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)	0.75 mL in 100 mL
WATER (UNII: 059QF0KO0R)	28.85 mL in 100 mL
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)	0.1 mL in 100 mL
LEMON OIL (UNII: I9GRO824LL)	0.3 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78109-070-03	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/14/2020

Labeler - Burwell Industries, Inc. (601637841)