EASE YOUR PAIN- menthol cream

Ease Your Pain by

Drug Labeling and Warnings

Ease Your Pain by is a Otc medication manufactured, distributed, or labeled by Proximity Capital Partners LLC dba Asutra, BioLyte Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol USP 4%

PURPOSE

Menthol USP 4% ........................... Topical Analgesic

INDICATIONS & USAGE

For the temporary relief of minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

Use only as directed.

For external use only. Keep away from excessive heat or flame.

When using this product:

• Avoid contact with eyse and mucous membranes
• Do not apply to wounds or damaged skin
• Do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments

Stop use and ask doctor if:

• Condition worsens
• Symptoms persist for more than 7 days, or clear up and occur again within a few days

If pregnant or breastfeeding: Ask a health professional before use.

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

DOSAGE & ADMINISTRATION

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:

• Consult physician.

STORAGE AND HANDLING

• Store in a cool, dry place.
• Avoid direct sunlight.
• Tamper-evident for your protection. Use only if safety seal is intact.
• Keep away from excessive heat or flame.

INACTIVE INGREDIENT

Aloe Vera Leaf Extract (BiAloe(R)), Arnica Montana, Calendula Officinalis Flower Extract, Carbomer, Citric Acid, Dimethyl Sulfone (MSM), Emu Oil, Ethyl Alcohol, Metyhl GLucose Dioleate, Potassium Sorbate, Purified Water, Sodium Hydroxide

QUESTIONS

888-819-6472

Monday - Friday, 9am - 5pm CT

Report any serious side effects to number above.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EASE YOUR PAIN 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72683-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EMU OIL (UNII: 344821WD61)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ARNICA MONTANA (UNII: O80TY208ZW)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ALCOHOL (UNII: 3K9958V90M)
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72683-002-01	1 in 1 CARTON	01/21/2019
1		85 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	01/21/2019

Labeler - Proximity Capital Partners LLC dba Asutra (081214985)

Establishment
Name	Address	ID/FEI	Business Operations
BioLyte Laboratories, LLC		015560564	manufacture(72683-002)