Kiss Therapy Medicated Lip Balm by Baja Fur, S.A. de C.V.

Kiss Therapy Medicated Lip Balm by

Drug Labeling and Warnings

Kiss Therapy Medicated Lip Balm by is a Otc medication manufactured, distributed, or labeled by Baja Fur, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KISS THERAPY MEDICATED LIP BALM- camphor, menthol, petrolatum stick 
Baja Fur, S.A. de C.V.

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.

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KISS THERAPY MEDICATED LIP BALM 
camphor, menthol, petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71413-208
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: 71413-208-02	1 in 1 BLISTER PACK	09/07/2017
1	NDC: 71413-208-01	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 - Baja Fur, S.A. de C.V. (821533098)

Revised: 9/2021

Document Id: cd2a4165-6f60-c35a-e053-2a95a90ae0ac

34390-5

Set id: cd2a4147-7ada-1210-e053-2a95a90a812c

Version: 1

Effective Time: 20210929