HAND SANITIZER- denatured dt ethyl alcohol liquid

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by SUN WAVE WELLNESS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Use(s)

To help reduce bacteria on the skin. 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
• around eyes
• in ears and mouth

When using this product

keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

• avoid contact with broken skin
• do not inhale or ingest

Stop use and ask a doctor if

irritation or rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and exessive heat above 40C (104F)

Inactive ingredients

Aloe Barbadenisis (leaf) Extract, Fragrance, Glycerin, Purified Water

Manufactured by:

Sun Wave Wellness, LLC

1419 Chaffee Drive #101

Titusville, FL 32780-7933

sunwavesanitizer.com

Drug Facts

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
denatured dt ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75023-004
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+)- (UNII: GFD7C86Q1W)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	26 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	2 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75023-004-01	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/05/2020
2	NDC: 75023-004-02	100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/05/2020
3	NDC: 75023-004-03	100 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	07/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/05/2020

Labeler - SUN WAVE WELLNESS, LLC (117465590)

Registrant - SUN WAVE WELLNESS, LLC (117465590)

Establishment
Name	Address	ID/FEI	Business Operations
SUN WAVE WELLNESS, LLC		117465590	manufacture(75023-004)