PanaHealth Instant Hand Sanitizer: Package Insert and Label Information

PANAHEALTH INSTANT HAND SANITIZER- alcohol gel
Panacea Life Sciences

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.

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with the Center for Disease Control (CDC) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (62%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Sterile distilled water or boiled cold water.

The firm adds inactive ingredients that do not effect the activity of the primary ingredient.

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer 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
  • 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 use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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. 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

Cannabidiol, dimethicone copolyoil, Carbomer, aloe barbadensis leaf juice, triethanolamine

Front and back labels for product

Rear label for productHand Sanitizer Front Label

PANAHEALTH INSTANT HAND SANITIZER
hand sanitizer gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74456-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 36.7 mL in 59 mL
Inactive Ingredients
Ingredient Name Strength
CANNABIDIOL 200 mg in 59 mL
ALOE VERA LEAF 0.6 mL in 59 mL
TRIETHANOLAMINE PHOSPHATE 0.5 mL in 59 mL
CARBOMER 1342 0.5 mL in 59 mL
DIMETHICONE 0.5 mL in 59 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74456-001-01 10000 mL in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/03/2020 04/03/2021
Labeler — Panacea Life Sciences (081187647)
Registrant — Panacea Life Sciences (081187647)
Establishment
Name Address ID/FEI Operations
Panacea Life Sciences 081187647 manufacture (74456-001)

Revised: 04/2020 Panacea Life Sciences

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.