Pure Essential Minerals Antibacterial Hand Sanitizer
FDA Label NDC 61577-1118

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sombra Cosmetics for the product Pure Essential Minerals Antibacterial Hand Sanitizer (NDC 61577-1118). 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, uses, 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

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

To decrease bacteria and viruses on the skin that could cause disease

Warnings

Flammable. Keep away from fire or flame. For external use only:  hands.

Do Not Use

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

When Using This Product

Keept out of the eyes.  In case of contact with eyes, flush shoroughly with water.  Avoid contact with broke skin.  Do not inhale or ingest.

Stop Use And Ask A Doctor

Stop use and ask a doctor if irritation or rash appears and lasts.  Condition persists for more than 72 hours.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.  For children under 6, use only under adult supervision.  Not recommended for infants.

Other Information

Do not store above 105F.  May discolor some fabrics.  May harm wood finishes.

Inactive Ingredients

Aloe Barba

* Please review the disclaimer below.