WELLENA SKINCARE HAND SANITIZER- hand sanitizer liquid

wellena skincare hand sanitizer by

Drug Labeling and Warnings

wellena skincare hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Hormone Balance Nutritionals, NIKO Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient[s]

Ethyl alcohol - 70 % (v/v)

Purpose

Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water is 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
• on open skin wounds

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

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

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°-30°C (59°-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Aqua, Glycerin, Xanthan Gum

wellena SKINCARE Hand Sanitizer - 120 mL

wellena

SKINCARE

HAND SANITIZER

70% ALCOHOL BASE

120 mL / 4 fl oz

NDC: 77011-070-13

Questions or report any adverse reactions to:

646.580.0121

Made in Canada

Manufactured for:

Hormone Balance Nutritionals

3980 Broadway 103, #137

Boulder, CO 80304

hormonebalancenutrionals.com

NONGMO

CRUELTY FREE

GLUTEN FREE

WOMEN OWNED

INGREDIENTS AND APPEARANCE

WELLENA SKINCARE HAND SANITIZER 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77011-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77011-070-13	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - Hormone Balance Nutritionals (117507500)

Establishment
Name	Address	ID/FEI	Business Operations
NIKO Cosmetics		257913475	manufacture(77011-070)