Optisafe Antiseptic Hand Sanitizer
FDA Label NDC 75043-060

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Babu Ram Om Prakash for the product Optisafe Antiseptic Hand Sanitizer (NDC 75043-060). 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.

Label Section Quick Index

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 • on broken skin

When using this product

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

• do not inhale or ingest.

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

aloe vera (Aloe barbadensis) leaf juice, carbomer 934, fragrance, glycerin, propylene glycol, tocopherol acetate (vitamin E), triethanolamine

Otc - Questions

Questions? +1-855-494-3767

You may also report serious side effects to this phone number. Mon-Fri 9.00 AM - 5.00 PM

Packaging

Optisfenew (Optisfenw)

Optisfenew (Optisfenw)

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