HAND SANITIZER- alcohol spray

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ECOTOMORROW LLC, AZS INDUSTRIA E COMERCIO EIRELI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the OTC Monograph not final part 333E.

The hand sanitizer is manufactured using only the following ingredients:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)).
2. Glycerol (1.60% v/v).
3. Melaleuca Alternifolio (Tea Tree) Oil.
4. Lavandula Angustifolia (Lavendar) Oil.
5. Aqua (Purified water).

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

• For washing hands to decrease bacteria on skin.
• Recommended for repeated use.

Warnings

• Flammable, keep away from heat or flame
• For external use only.

Do not use

For external use only.

WHEN USING

When using

• Avoid contact with eyes.
• If contact occurs, rinse eyes thoroughly with water.
• Avoid contact with broken skin

STOP USE

Stop use and ask a doctor if redness or irritation appears and lasts.

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

• Wet hands thoroughly with product and allow to dry without wiping.
• Supervise children in the use of this product.
• Use only as directed.

Other information

• Store at room temperature 68-77F
• May discolor certain fabrics or surfaces.

Inactive ingredients

aqua (purified water), glycerin, lavandula angustifolia oil, melaleuca alternifolio leaf oil

Package Label - Principal Display Panel

120mL NDC: 77770-001-01

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77770-001
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
GLYCERIN (UNII: PDC6A3C0OX)	1.6 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77770-001-01	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2020	07/31/2023

Labeler - ECOTOMORROW LLC (117522249)

Establishment
Name	Address	ID/FEI	Business Operations
AZS INDUSTRIA E COMERCIO EIRELI		944838856	manufacture(77770-001)