NDC Code(s) : 59998-101-14, 59998-101-12, 59998-101-10
Packager : Bio-Germ Protection LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BIOCENCEEUCALYPTOL THYMOL LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59998-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL(UNII: RV6J6604TK)
(EUCALYPTOL - UNII:RV6J6604TK) 		EUCALYPTOL0.091 g in 100 mL
THYMOL(UNII: 3J50XA376E)
(THYMOL - UNII:3J50XA376E) 		THYMOL0.063 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
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)
ALMOND OIL(UNII: 66YXD4DKO9)
YELLOW WAX(UNII: 2ZA36H0S2V)
CASTOR OIL(UNII: D5340Y2I9G)
COCONUT OIL(UNII: Q9L0O73W7L)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59998-101-14118 mL in 1 BOTTLE Type 0: Not a Combination Product26/10/2012
2NDC:59998-101-1260 mL in 1 BOTTLE Type 0: Not a Combination Product26/10/2012
3NDC:59998-101-1012 mL in 1 APPLICATOR Type 0: Not a Combination Product26/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M003 10/26/2012

LABELER - Bio-Germ Protection LLC(175770234)

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