Hand Sanitizer
FDA Label NDC 78336-170

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Charles And Associates, Llc for the product Hand Sanitizer (NDC 78336-170). 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, use, warnings, 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

→ Other

→ Active Ingredient(s)

→ Purpose

→ Use

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ 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):

Alcohol (71%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerol (0.5% v/v).
Carbomer (8.0% v/v).
Trolamine (1.0% v/v).
Sterile distilled water or boiled cold water.

Active Ingredient(S)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin that potentially can cause sickness, recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat and flame.

Otc - When Using

Avoid contact with eyes, ears, and mouth. If contact does occur, flush with water.

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help, or contact poison control center right away.

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develop and presists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help, or contact poison control center right away.

Directions

Apply a small amount to palms, rubbing briskly to cover both hands until dry - repeat as necessary.
Supervise children under 6 years with the use of this product. Do not use on infants.