KEVO-PROPHEN- juniper tar cream

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Juniperus Oxycedrus (Juniper Tar Oil) 1%

Purpose

pain reliever

Use

For the temporary relief of pain

Warnings

• For External Use Only
• Use only as directed
• Read and follow directions on label
• Avoid contact with eyes and muscous membranes.
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
• If pregnant or breast feeding, ask a physician before use.

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

DO NOT USE

• on puncture wounds
• on cut, irritated, or open skin.

Directions

• Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: do not use, consult a physician.
  

Inactive Ingredients

Abies Balsamea Needle Oil, beta-Caryophyllene, Bisabolol, Calophyllum lnophyllum Seed Oil*, Carthamus
Tinctorius Oleosomes, Cedrus Deodara Wood Oil, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Palmitate,
Copaifera Officinalis, Glyceryl Stearate SE, Lecithinl, Litsea Cubeba, Methylsulfonylmethane, Nigella Sativa
Seed Oil*, Ocimum Basilicum Oil, Origanum Vulgare, Persea Gratissima, Piper Nigrum Seed Oil, Potassium
Sorbate, Pullulan, Salix Nigra Bark Extract, Sclerotium Gum, Sodium Benzoate, Sorbitan Oleate, Sorbitan
Olivate, Stearic Acid, Theobroma Cacao Seed Butter, Vanilla Planifolia Oil, Water (Aqua), Xanthan Gum.

Questions or Comments

www.faeveusa.com

(352) 593-3352

Made in USA

Package - Box

INGREDIENTS AND APPEARANCE

KEVO-PROPHEN 
juniper tar cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87607-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
JUNIPER TAR (UNII: 1Q84T0P2G3) (JUNIPER TAR - UNII:1Q84T0P2G3)	JUNIPER TAR	0.2835 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITAN OLIVATE (UNII: MDL271E3GR)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
OCIMUM BASILICUM (BASIL) OIL (UNII: Z129UMU8LE)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
LITSEA CUBEBA FRUIT OIL (UNII: 2XIW34BN6O)
TAMANU OIL (UNII: JT3LVK84A1)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
PERSEA GRATISSIMA (AVOCADO) OIL (UNII: 6VNO72PFC1)
BETA-CARYOPHYLLENE (UNII: BHW853AU9H)
BISABOLOL (UNII: 24WE03BX2T)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
COPAIFERA OFFICINALIS RESIN OIL (UNII: PZA3DGE9YF)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
PULLULAN (UNII: 8ZQ0AYU1TT)
SORBITAN OLEATE (UNII: 06XEA2VD56)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
ABIES BALSAMEA (BALSAM CANADA) NEEDLE OIL (UNII: 2FGT9T2SQC)
PIPER NIGRUM (PEPPER) SEED OIL (UNII: 2AM83DL9FV)
WATER (UNII: 059QF0KO0R)
ORIGANUM VULGARE LEAF OIL (UNII: 7D0CGR40U1)
SCLEROTIUM GUM (UNII: 2X51AD1X3T)
CEDRUS DEODARA WOOD OIL (UNII: 01O086PVD0)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87607-001-01	1 in 1 BOX	04/20/2026
1		98 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/20/2026

Labeler - Faeve, LLC (127765108)