Label: BIOCENCE- eucalyptol thymol lotion
- NDC Code(s): 59998-101-10, 59998-101-12, 59998-101-14
- Packager: Bio-Germ Protection LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 25, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
-
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.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIOCENCE
eucalyptol thymol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59998-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.091 g in 100 mL THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 0.063 g in 100 mL Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) YELLOW WAX (UNII: 2ZA36H0S2V) CASTOR OIL (UNII: D5340Y2I9G) COCONUT OIL (UNII: Q9L0O73W7L) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) BETASIZOFIRAN (UNII: 2X51AD1X3T) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) OLIVE OIL (UNII: 6UYK2W1W1E) CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PEPPERMINT OIL (UNII: AV092KU4JH) ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M) TEA TREE OIL (UNII: VIF565UC2G) THYME OIL (UNII: 2UK410MY6B) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) METHYL SALICYLATE (UNII: LAV5U5022Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59998-101-14 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/26/2012 2 NDC:59998-101-12 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/26/2012 3 NDC:59998-101-10 12 mL in 1 APPLICATOR; Type 0: Not a Combination Product 10/26/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/26/2012 Labeler - Bio-Germ Protection LLC (175770234) Registrant - Bio-Germ Protection LLC (175770234)