EXTRA STRENGTH AND MUSCLE RELIEF 900 MG- menthol and lidocaine gel

EXTRA STRENGTH AND MUSCLE RELIEF 900 mg by

Drug Labeling and Warnings

EXTRA STRENGTH AND MUSCLE RELIEF 900 mg by is a Otc medication manufactured, distributed, or labeled by Lifecure Rx Specialty Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

Temporary relief of minor arthritis, backache, muscle and joint pain

Warnings

For external use only
Allergy alert: If prone to allergic reaction to latex, consult a doctor before use. Symptoms may include: rash blisters skin reddening
If a skin reaction occurs, stop use and seek medical help right away.

Directions

adults and children 12 and older: Apply 1 to 4 pumps to areas of pain and discomfort. Reapply as necessary using no more than 4 times daily.
children under the age of 12: Do not use, ask a doctor

When using this product:

Use only as directed Avoid contact with eyes and mucous membranes do not use with a heating pad do not bandage tightly

do not apply to wounds or damaged skin

Stop and ask doctor if

condition worsens symptoms last for more than 7 days symptoms clear up and occur again within a few days redness or irritation occurs

storage

Store at 20-35 deg C (68-77deg F).

Keep out of reach of children and pets

If swallowed, get medical help or contact poison control right away.

Active Ingredients & Purpose

Menthol 4%----------------- Analgesic

Lidocaine 3%--------------- Analgesic

Inactive Ingredient

bergamot oil, carbomer 940, caderwood oil, devil' claw extract, ethanol, geranium oil, Glydant Plus, hemp extract cannabidiol oil, horse chestnut seed extract, lavender oil, oleic acid, propylene glycol, purified water, soya photidylcholine, triethanolamine.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH AND MUSCLE RELIEF 900 MG 
menthol and lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72800-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BERGAMOT OIL (UNII: 39W1PKE3JI)
CARBOMER 934 (UNII: Z135WT9208)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
ALCOHOL (UNII: 3K9958V90M)
GERANIUM THUNBERGII FLOWERING TOP (UNII: 9IXM1668B6)
HEMP (UNII: TD1MUT01Q7)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
OLEIC ACID (UNII: 2UMI9U37CP)
1,2-DILINOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 7L874P1M1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72800-002-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/05/2019

Labeler - Lifecure Rx Specialty Pharmacy (116913965)

Establishment
Name	Address	ID/FEI	Business Operations
Lifecure Rx Specialty Pharmacy		116913965	manufacture(72800-002)