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NDC 58611-0032-04 Phoenix KinetiCream Anti-inflammatory and Pain Relief 20 mg/mL Details

Phoenix KinetiCream Anti-inflammatory and Pain Relief 20 mg/mL

Phoenix KinetiCream Anti-inflammatory and Pain Relief is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Phoenix Bioperformance Products, LLC. The primary component is MENTHOL.

Product Information

NDC	58611-0032
Product ID	58611-032_b69ae790-4600-38e5-e053-2a95a90aad02
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Phoenix KinetiCream Anti-inflammatory and Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
Labeler Name	Phoenix Bioperformance Products, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 58611-0032-04 (58611003204)

Pricing Information	N/A
NDC Package Code	58611-032-04
Billing NDC	58611003204
Package	118 mL in 1 TUBE (58611-032-04)
Marketing Start Date	2017-02-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 05b22901-c6c8-4f84-aa93-25597420e775 Details

Drug Facts

Active Ingredients

Menthol 2.00%

Purpose

Topical Pain Relief

Uses

temporary relieves of these symptoms:

minor aches
pains associated with simple backache
arthritis
bruises
sprains
cramps
muscle strains.

Warnings

For external use only.

Use only as directed children under 6 years, ask a doctor.

Stop use and ask a doctor if:

condition worsen
pain persist of more than 7 days
irritation develops

Avoid contact with eyes and open wounds.

If swallowed, get medical help or contact your local Poison Control Center or emergency room immediately.

If pregnant or breast feeding

ask a health professional before use.

Keep out of reach of children.

Directions

Adults and children 6 years and over:

Before activity, massage onto muscles and joints until absorbed into skin.
After activity, apply generously to tired and affected areas
Apply to dry and cleans areas
Repeat as needed, up to 6 times daily.

Inactive ingredients:

Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), arnica montana (arnica) extract, azadirachta indica (neem) oil, bromelain, butyrospermum parkii (shea) butter, C13-14 isoparaffin, camellia sinensis (green tea) leaf extract, cetearyl alcohol, chondroitin sulfate, citric acid, citrus aurantium bergamia (bergamot) fruit oil, dimethyl sulfone (MSM), emu oil, ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate SE, laureth-7, mentha piperita (peppermint) oil, papain, phenoxyethanol, polyacrylamide, polysorbate-20, salix alba (willow) bark extract, SD-Alcohol 40B, sesamum indicum (sesame) seed oil, stearic acid, theobroma cacao (cocoa butter), tocopheryl acetate (vitamin E), xanthan gum.

Product Label

INGREDIENTS AND APPEARANCE

PHOENIX KINETICREAM ANTI-INFLAMMATORY AND PAIN RELIEF

menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58611-032
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
BROMELAINS (UNII: U182GP2CF3)
SHEA BUTTER (UNII: K49155WL9Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BERGAMOT OIL (UNII: 39W1PKE3JI)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
LAURETH-7 (UNII: Z95S6G8201)
PEPPERMINT OIL (UNII: AV092KU4JH)
PAPAIN (UNII: A236A06Y32)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WILLOW BARK (UNII: S883J9JDYX)
SESAME OIL (UNII: QX10HYY4QV)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58611-032-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	02/22/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/22/2013

Labeler - Phoenix Bioperformance Products, LLC (034681162)

Revised: 12/2020

Document Id: b69ae790-4600-38e5-e053-2a95a90aad02

Set id: 05b22901-c6c8-4f84-aa93-25597420e775

Version: 5

Effective Time: 20201216