Wellena Skincare Hand Sanitizer: Package Insert and Label Information

WELLENA SKINCARE HAND SANITIZER- alcohol liquid
Hormone Balance Nutritionals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

image description
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WELLENA SKINCARE HAND SANITIZER
hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77011-070
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
XANTHAN GUM
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77011-070-13 120 mL in 1 BOTTLE None
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 Operations
NIKO Cosmetics 257913475 manufacture (77011-070)

Revised: 05/2020 Hormone Balance Nutritionals

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