PENETRATING PAIN RELIEF JAXSENS- menthol lotion

Penetrating Pain Relief by

Drug Labeling and Warnings

Penetrating Pain Relief by is a Otc medication manufactured, distributed, or labeled by COSMETIC ENTERPRISES LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient    Purpose

Menthol 7.5%       Topical Analgesic

PURPOSE

Uses  For the relief of aches and pains of muscles and joints associated with arthritis, backache, strains, bruises, and cramps

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

INDICATIONS & USAGE

Stop use and ask a doctor if rash irritation of skin develops and lasts.

• Condition worsens or symptoms persist for more than 7 days

• Symptoms clear up and occur again within a few days

WARNINGS

Warnings: For external  use only

When using this product

• avoid contact with the eyes or mucous  membranes

• do not bandage tightly

Ask a doctor before use

• If there is redness over affected area

Do not use

• on wounds or damaged skin

• With a heat pad

DOSAGE & ADMINISTRATION

Directions ​​use only as directed

apply to painful area 3 to 4 times daily gently massage the cream into skin

children under 6 years of age: consult a doctor

INACTIVE INGREDIENT

Acrylates/C10-C30 Alkyl Acrylate Crosspolymer, Arnica Montana Flower extract, Boswella Serrata Extract, Calendula Officinalis Extract, Caprylic/Capric Triglycerides, Caprylyl Glycol, Carbomer, Chamomilla recutita (Matricaria) Flower Extract, Chondroiton Sulfate, Chrysanthemum Panthenium (Feverfew) Extract, Citric Acid, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root Extract, Dimethyl Isosorbide, Dimethyl Sulfone,  Emulsifying Wax, Glucosamine HCL, Glycerin, Glyceryl Stearate, Harpagophytum Procumbens Root Extract, Hydrogenated Methyl Abietate, Lonicera Caprifolium Extract, Lonicera Japonica Extract, Menthyl Lactate, Phenoxyethanol, Potassium Sorbate, Sodium Hydroxide, Symphytum Officinale (Comfrey) Leaf Extract, Tocoherol, Urtica Dioica(Nettle) Leaf Extract, Vanillyl Butyl Ether, Water/Aqua, Xanthan Gum.

PRINCIPAL DISPLAY PANEL

Jaxsens

Provides Penetrating Pain Relief

Patented Formula for muscle and Joint Pain

Net. Weight 4 oz(113.4g)

INGREDIENTS AND APPEARANCE

PENETRATING PAIN RELIEF  JAXSENS
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-5006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
FEVERFEW (UNII: Z64FK7P217)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
TURMERIC (UNII: 856YO1Z64F)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
LONICERA JAPONICA TOP (UNII: 60Q6UP226V)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COMFREY LEAF (UNII: DG4F8T839X)
TOCOPHEROL (UNII: R0ZB2556P8)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-5006-1	113.4 g in 1 PACKAGE; Type 0: Not a Combination Product	12/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/13/2018

Labeler - COSMETIC ENTERPRISES LTD (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIC ENTERPRISES LTD		017701475	manufacture(56152-5006)