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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Available from:
Lifecure Rx Specialty Pharmacy
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporary relief of minor arthritis, backache, muscle and joint pain Menthol 4%----------------- Analgesic Lidocaine 3%--------------- Analgesic
Authorization status:
OTC monograph not final
Authorization number:
72800-002-30

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

Lifecure Rx Specialty Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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EXTRA STRENGTH JOINT AND MUSCLE RELIEF GEL

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

s torage

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.

EXTRA STRENGTH AND MUSCLE RELIEF 900 MG

menthol and lidocaine gel

Product Information

Lifecure Rx Specialty Pharmacy

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:728 0 0 -0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

40 mg in 1 mL

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

30 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BERGAMO T O IL (UNII: 39 W1PKE3JI)

CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )

JUNIPERUS VIRGINIANA O IL (UNII: PAD4FN7P2G)

HARPAGO PHYTUM PRO CUMBENS RO O T (UNII: 1OYM338 E8 9 )

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GERANIUM THUNBERGII FLO WERING TO P (UNII: 9 IXM16 6 8 B6 )

HEMP (UNII: TD1MUT0 1Q7)

HO RSE CHESTNUT (UNII: 3C18 L6 RJAZ)

LAVANDULA ANGUSTIFO LIA SUBSP. ANGUSTIFO LIA FLO WER (UNII: 19 AH1RAF4M)

O LEIC ACID (UNII: 2UMI9 U37CP)

1,2 -DILINO LEO YL-SN-GLYCERO -3 -PHO SPHO CHO LINE (UNII: 7L8 74P1M1O)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:728 0 0 -0 0 2-30

30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 5/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/0 5/20 19

Labeler -

Lifecure Rx Specialty Pharmacy (116913965)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Lifecure Rx Specialty Pharmacy

116 9 139 6 5

ma nufa c ture (728 0 0 -0 0 2)

Revised: 3/2019

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