Biocence (as Pld) - Lotion (59998-101)

Biocence (as Pld) - Lotion (59998-101)
SPL v13
SPL
SPL Set ID 1ea56ac9-4fc2-41c0-adda-5a2c55bef696
Route
TOPICAL
Published
Effective Date 2012-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.091 g) Thymol (0.063 g)
Inactive Ingredients
Eucalyptus Globulus Leaf Glycerin Glyceryl Monostearate Betasizofiran Lecithin, Soybean Olive Oil Citrus Aurantium Flower Vitamin A Palmitate Peppermint Oil Rosmarinus Officinalis Whole Tea Tree Oil Thyme Oil Tocopherol Water Methyl Salicylate Almond Oil Yellow Wax Castor Oil Coconut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-10-26

Description

ACTIVE INGREDIENTS EUCALYPTOL 0.091% THYMOL 0.063%


Medication Information

Warnings and Precautions

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.
Indications and 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.
Dosage and 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.
Description

ACTIVE INGREDIENTS EUCALYPTOL 0.091% THYMOL 0.063%

Section 50565-1
  • KEEP OUT OF REACH OF CHILDREN.
  • IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Section 51727-6

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.

Section 51945-4

Section 53413-1

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

WWW.BIOCENCE.COM OR WWW.BIO911TRUST.COM

Section 55105-1

PURPOSE

ANTISEPTIC

Section 55106-9

ACTIVE INGREDIENTS

EUCALYPTOL 0.091%

THYMOL 0.063%

Section 60561-8

OTHER INFORMATION

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

Structured Label Content

Indications and Usage (34067-9)

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.
Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

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.
Section 50565-1 (50565-1)
  • KEEP OUT OF REACH OF CHILDREN.
  • IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

WWW.BIOCENCE.COM OR WWW.BIO911TRUST.COM

Section 55105-1 (55105-1)

PURPOSE

ANTISEPTIC

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS

EUCALYPTOL 0.091%

THYMOL 0.063%

Section 60561-8 (60561-8)

OTHER INFORMATION

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

Advanced Ingredient Data


Raw Label Data

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