Active Ingredient(s)

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

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 excessive heat above 40C (104F).

Inactive ingredients

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

Sanitizer pkg001 ANTISEPTIC

HAND

SANITIZER

SPRAY GEL

ALCOHOL ANTISEPTIC 70%

enriched with aloe

CLEAN SCENT

TOPICAL SOLUTION

KILLS

GERMS &

BACTERIA

3.4OZ 100ML

NO-STERILE SOLUTION

SUN WAVE CONSUMER ANTISEPTIC HAND SANITIZER
isopropyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75023-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75023-001-01	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/30/2020

Labeler - SUN WAVE WELLNESS, LLC (117465590)

Registrant - SUN WAVE WELLNESS, LLC (117465590)

Name	Address	ID/FEI	Business Operations
Establishment
SUN WAVE WELLNESS LLC		117465590	manufacture(75023-001)

CONSUMER HAND SANITIZER; NON-EMERGENCY; ISOPROPYL ALCOHOL = DEFERRED GRASE ACTIVE INGREDIENT DETERMINATION EFFECTIVE APRIL 13, 2020; PART333E FOR OTC HAND RUB SANITIZERS (CONSUMER)