Wellena Skincare Hand Sanitizer
FDA Label NDC 77011-070

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hormone Balance Nutritionals for the product Wellena Skincare Hand Sanitizer (NDC 77011-070). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient[s], purpose, use[s], warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Otc - When Using

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

Otc - Stop Use

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

Otc - 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°-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 (Wellena 120)

Image Description (Wellena 120)

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