Biocence Lotion
FDA Label NDC 59998-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bio-germ Protection Llc for the product Biocence (NDC 59998-101). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

ACTIVE INGREDIENTS

EUCALYPTOL 0.091%

THYMOL 0.063%

Otc - Purpose

PURPOSE

ANTISEPTIC

Indications & Usage

USES

  • A MULTIPLE USE ANTISEPTIC
  • CONTAINING PREPARATION DESIGNED FOR FREQUENT USE WITHOUT WATER AS AN ANTISEPTIC HANDWASH AND FIRST AID ANTISEPTIC.
  • HELPS TO PROTECT AGAINST SKIN INFECTION AND TO HELP PREVENT CROSS CONTAMINATION IN CUTS, SCRAPES, BURNS, AND OR SECONDARY INFECTIONS.

Warnings

WARNINGS

FOR EXTERNAL USE ONLY.

  • DO NOT USE IN EYES OR APPLY OVER LARGE AREAS OF THE BODY.
  • IN CASE OF DEEP OR PUNCTURE WOUNDS, ANIMAL BITES, OR SERIOUS BURNS, CONSULT A PHYSICIAN.
  • STOP OR CONSULT A PHYSICIAN IF CONDITIONS PERSIST OR GET WORSE.
  • DO NOT USE LONGER THAN ONE WEEK UNLESS DIRECTED BY A PHYSICIAN.

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.

Dosage & Administration

DIRECTIONS

  • CLEAN THE AFFECTED AREA.
  • APPLY A SMALL AMOUNT OF THIS PRODUCT ON THE AREA 1 TO 3 TIMES DAILY.
  • BANDAGE LIGHTLY.
  • KEEP BANDAGE WET WITH SOLUTION.
  • MAY BE COVERED WITH STERILE BANDAGE.
  • IF BANDAGED, LET DRY FIRST.

Other Safety Information

OTHER INFORMATION

  • SHAKE WELL BEFORE USE.
  • STORE AT 59° TO 85°F

Inactive Ingredient

INACTIVE INGREDIENTS

PRUNUS AMYGDALUS DULIS (SWEET ALMOND) OIL, BEESWAX, CASTOR SEED OIL, COCOS NUCIFERA (COCONUT) OIL, EUCALYPTUS GLOBULUS LEAF OIL, GLYCERIN, GLYCERYL STEARATE, SCLEROTIUM GUM, LECITHIN, OLEA EUROPAEA (OLIVE) FRUIT OIL, BITTER ORANGE EXTRACT, RETINYL PALMITATE, MENTHA PIPERITA (PEPPERMINT) OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, THYMUS VULGARIS (THYME) OIL, TOCOPHEROL, WATER (AQUA), GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF OIL.

Otc - Questions

QUESTIONS? CALL 310-295-9699 P.S.T. 9AM - 5PM MONDAY-THURSDAY OR VISIT

WWW.BIOCENCE.COM OR WWW.BIO911TRUST.COM

Package Label.Principal Display Panel

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