NDC | 12027-208-01, 12027-208-02 |
Set ID | 589e1060-27da-5c4d-e053-2991aa0a1d07 |
Category | HUMAN OTC DRUG LABEL |
Packager | Markwins Beauty Products, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KISS THERAPY MEDICATED LIP BALM
camphor, menthol, petrolatum stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12027-208 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.8 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 30 g in 100 g CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 0.8 g in 100 g Inactive Ingredients Ingredient Name Strength TRIHYDROXYSTEARIN (UNII: 06YD7896S3) ALOE VERA LEAF (UNII: ZY81Z83H0X) YELLOW WAX (UNII: 2ZA36H0S2V) COCONUT OIL (UNII: Q9L0O73W7L) KONJAC MANNAN (UNII: 36W3E5TAMG) SHEA BUTTER (UNII: K49155WL9Y) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYL PALMITATE (UNII: 2865993309) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PHENOXYETHANOL (UNII: HIE492ZZ3T) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) PEPPERMINT OIL (UNII: AV092KU4JH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) EUCALYPTUS OIL (UNII: 2R04ONI662) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TRIBEHENIN (UNII: 8OC9U7TQZ0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12027-208-02 1 in 1 BLISTER PACK 09/07/2017 1 NDC:12027-208-01 3.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/07/2017 Labeler - Markwins Beauty Products, Inc. (135407760) Establishment Name Address ID/FEI Business Operations Baja Fur, S.A. de C.V. 821533098 manufacture(12027-208) , label(12027-208) , pack(12027-208)