Serene Clean And Pure Hand Sanitizer Gel
FDA Label NDC 78643-110

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Serene Clean & Pure Llc for the product Serene Clean And Pure Hand Sanitizer Gel (NDC 78643-110). 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, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor, 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

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Label - Principal Display Panel

Active Ingredient

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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.

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

Water, carbomer, glycerin

Package Label - Principal Display Panel

Serene Clean & Pure

Kills 99.9% of All Germs & Bacteria

Gel Hand Sanitizer

70% Isopropyl Alcohol

www.serenepure.com

ABOUT

Serene Clean & Pure is a family owned company that believes in honest and helpful products.

Serene Clean & Pure is a quickly drying hand sanitizer that leaves hands feeling gentle and soft, while moisturizing them. Use as often as needed for a germ and bacteria free life

Distributed by:

Serene Clean & Pure

555 Anton Blvd. Suite 105

Costa Mesa, CA 92626

2 fl. oz.