Kay Medic Menthol Pain Relief (Menthol) Cream [Kay Medic Llc] -

KAY MEDIC MENTHOL PAIN RELIEF (MENTHOL) CREAM [KAY MEDIC LLC]
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NDC	69542-555-01
Set ID	00e64e31-e674-4d8f-9b68-a14b7002386f
Category	HUMAN OTC DRUG LABEL
Packager	Kay Medic LLC
Generic Name
Product Class
Product Number
Application Number	PART348

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ACTIVE INGREDIENTS

Menthol 3.00%
PURPOSE

External Analgesic
USES

for the temporary relief of minor aches, and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
WARNINGS
- For external use only. Avoid contact with eyes, nose, mouth and genitalia.
- Use only as directed.
- Do not apply to open wounds or damaged skin.
- Do no bandage tightly
ASK DOCTOR

Ask a doctor before use if you have sensitive skin.
Keep out of reach of children.

If swallowed, contact your local poision control center or emergency room immediately.
STOP USE

If symptoms persist for more than seven days, discontinue use and consult physician.
PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, contact physcian prior to use.
DIRECTIONS:

Adults and children 12 years of age or older: apply to affected area not more than 3 or 4 times daily.

Children under 12 years of age: ask a doctor before use.
OTHER INGREDIENTS

Acorus Calamus (Sweet Flag/Shi Chang Pu) Rhizome Extract,Aloe Barbadensis Leaf Extract (Aloe Vera Gel), Angelica Dahurica Root Extract, Angelica Sinensis Root Tip Extract, Aqua (Deionized Water), Arisaema(Jack-In The-Pulpit) Rhizome Processed With Bovine Bile (Bile Arisaema/Dan Nan Xing) Extract; Bis-Vinyl Dimethicone/Dimethicone Copolymer; Boswellia Sacra (Frankincense/Olivanum) Resin; Cancer Irroratus (Atlantic Rock Crab) Carapace Extract; Carthamus Tinctorius (Safflower) Extract; Cetyl Alcohol; Chondroitin Sulfate; Cimicifuga Racemosa (Climicifuga) Root Extract; Commiphora Myrrha Resin Extract;Cyclopentasiloxane; Dracaena Cinnabari (Dragon's Blood) Resin Extract;Fossilized Mammals Bones ("Dragon" Bones/Long Gu) Extract; Glucosamine Sulfate; Glycerin; Glyceryl Stearate, Ledebouriella Divaricata (Ledebouriella/Fang Feng) Root Extract; Ligusticum Wallichii (Szechuan Lovage/Chuanxiong) Root Extract; Methylsulfinylmethane (Msm); Notopterygium Incisum (Notopterygium) Root Extract; Peg-100 Stearate; Peg-12 Dimethicone; Phenoxyethanol; Polysorbate-20; Propylene Glycol; Stearic Acid; Strychnos Nux-Vomica (Strychnine Tree/Yanhusuo) Extract.
Pakage Labeling

KAY MEDIC

MENTHOL PAIN RELIEF CREAM

1oz. (29.5735mL)

Manufactured for Kay Medic LLC, Davie, Florida, 33331 USA

Questions or comments? Call 1-888-217-8628 (English)

INGREDIENTS AND APPEARANCE

KAY MEDIC MENTHOL PAIN RELIEF
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69542-555
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
WATER (UNII: 059QF0KO0R)
ARISAEMA ERUBESCENS ROOT (UNII: 3E8P1PU8SY)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
FRANKINCENSE (UNII: R9XLF1R1WM)
ATLANTIC ROCK CRAB (UNII: 2K19902G3Q)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
BLACK COHOSH (UNII: K73E24S6X9)
MYRRH (UNII: JC71GJ1F3L)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MAMMAL BONE, FOSSILIZED (UNII: 0N1T3913DA)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)
PEG-100 STEARATE (UNII: YD01N1999R)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
STRYCHNOS NUX-VOMICA WHOLE (UNII: AB2NX17POS)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69542-555-01	29.5 mL in 1 JAR; Type 0: Not a Combination Product	02/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/21/2015

Labeler - Kay Medic LLC (037429127)

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