Hand Sanitizer
FDA Label NDC 78359-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Junior Chemical Products Care S.a. De C.v. for the product Hand Sanitizer (NDC 78359-001). 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 other, active ingredient(s), purpose, otc - when using, use, otc - stop use, warnings, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient(s)

→ Purpose

→ Otc - When Using

→ Use

→ Otc - Stop Use

→ Warnings

→ Do Not Use

→ Otc - Keep Out Of Reach Of Children

→ Other Information

→ Inactive Ingredients

→ Directions

→ Package Label - Principal Display Panel

Other

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 World Health Organization (WHO) recommendations:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Glycerin (1.45% v/v).

Triethanolamine capryol glutamate (0.12% v/v).

Sterile distilled water or boiled cold water.

Carbomer 980 (0.86% v/v)

Aloe vera leaf (0.02% v/v)

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(S)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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.
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.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Otc - Stop Use

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

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 - 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.

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

glycerin, carbomer, triethanolamine caproyl glutamato, aloe vera leaf, purified water USP

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.