Bufferin Hand Sanitizer
FDA Label NDC 50066-608

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Bufferin Hand Sanitizer (NDC 50066-608). 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, purpose, uses, warnings, when using this product, 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

Drug Facts

Distributed by: Genomma Lab USA
Inc., Houston, TX, 77027

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

  • To decrease bacteria on the skin when water, soap & towel are not available
  • Recommended for repeated use.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When Using This Product

  • Keep out of eyes. In case of contact with eyes, rinse thoroughly with water
  • Do not use on broken or irritated skin.

Otc - Stop Use

Stop use and ask a doctor if irritation or redness develop and last more than 72 hours.

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

  • Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other Information

  • Do not store above 105 °F (40 °C).
  • May discolor certain fabrics and wood surfaces.

Inactive Ingredients

water, carbomer, triethanolamine, fragrance, propylene glycol, glycerin, aloe barbadensis extract, tocopheryl acetate.

Questions?

Call toll free 1-877-994-3666 Monday to Friday, 8am to 6pm, Central time

Principal Display Panel - 236 Ml Bottle Label

The Science
of Healthy Hands

70% ETHYL ALCOHOL
SOURCED IN THE USA

BUFFERIN®
HAND SANITIZER

Antibacterial Gel

KILLS 99.99%
OF BACTERIA

enriched with
Vitamin E & Aloe

8 fl oz
(236 ml)

2000009663
S-20N092

Principal Display Panel (236 ml Bottle Label)

Principal Display Panel (236 ml Bottle Label)

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