Palma Hand Sanitizer Gel
FDA Label NDC 81286-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unitrade Fze for the product Palma Hand Sanitizer (NDC 81286-101). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin  • recommended for repeated use  • for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame
For external use only

Do not use  • in children less than 2 months of age  • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if  • irritation and redness develop  • condition persists 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 a Poison Control Center right away.

Directions

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Other Information

• store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

water, caprylic /capric triglyceride, avocado (Persea gratissima) oil, propylene glycol, glycerin, jojoba (Simmondsia chinensis) seed oil, peg-40 hydrogenated castor oil, polyacrylamide, c13-14 isoparaffin, laureth-7, acrylates / c10-30 alkyl acrylates crosspolymer, niacinamide, sodium hyaluronate, tocopheryl acetate, panthenol, gotu kola (Centella asiatica) root extract, triethanolamine, fragrance.

Questions? 1-516-535-5555

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Packaging

Image Description (81286 101 3)

Image Description (81286 101 3)

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