HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Savvy Wellness, MaxPax LLC, Flavorcraft LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a gel hand sanitizer manufactured using only United States Pharmacopoeia (USP) grade ingredients in the preparation of the product.

Active Ingredient(s)

Alcohol 80% v/v.

Purpose

Antiseptic

Use

Hand rub to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

In children less than 2 months of age and on open skin wound.

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Purified water USP, PEG 300, aloe vera, hydroxyethyl cellulose, sodium hydroxide, tocopheral acetate, cassia bark oil, lavender oil, tea tree oil, lemon peel oil.

Package Label - Principal Display Panel

1.25 mL NDC: 79027-001-01

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79027-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.01 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.03 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	15.98 mL  in 100 mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)	1.06 mL  in 100 mL
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)	1.46 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	1.46 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79027-001-01	1.25 mL in 1 POUCH; Type 0: Not a Combination Product	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/29/2020

Labeler - Savvy Wellness (094766868)

Establishment
Name	Address	ID/FEI	Business Operations
MaxPax LLC		017038858	pack(79027-001)

Establishment
Name	Address	ID/FEI	Business Operations
Flavorcraft LLC		621632921	manufacture(79027-001)