DICLOCAINE- lidocaine 4.5%, diclofenac 1.25% patch

Diclocaine by

Drug Labeling and Warnings

Diclocaine by is a Otc medication manufactured, distributed, or labeled by Terrain Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each patch):

Diclofenac Sodium (NSAID) 1.25% Arthritis Pain Reliever

Lidocaine 4.5% Topical Anesthetic

PURPOSE

USES:

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

• Muscle soreness
• Strains
• Sprains
• Arthritis
• Simple backache
• Muscle stiffness
• Bruises

WARNINGS

WARNINGS:

For external use only

Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you:

• Are age 60 or older
• Have had stomach ulcers or bleeding problems
• Take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others)
• Take a blood thinning (anticoagulant) or steroidal drug
• Have three or more alcoholic drinks every day while using this product
• Take more or for a longer time than directed

Do not use:

• On the face or rashes
• On wounds or damaged skin
• In the eyes, mouth, or other mucous membranes
• On genitals
• With a heating pad
• If allergic to any NSAID’s
• Right before or after heart surgery
• Any patch from a pouch that has been opened for 7 or more days

Ask a doctor before use if:

• You are allergic to topical products
• The stomach bleeding warning applies to you
• You are taking a diuretic
• You have high blood pressure, heart disease, or kidney disease
• You are pregnant

When using this product:

• Wash hands after applying or removing patch
• Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water
• The risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and consult your physician if:

• Stomach pain or upset gets worse or lasts
• Rash, irritation, or itching develops
• You feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding)
• Condition worsens

If pregnant or breast feeding, ask a doctor before use while breast feeding and during the first 6 months of pregnancy. Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children, if put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.

DOSAGE & ADMINISTRATION

Adults, or children over the age of 12:

Apply patch to affected are 1 to 2 times daily or as directed

INDICATIONS & USAGE

INSTRUCTIONS FOR USE:

• Clean and dry affected area
• Open pouch and remove one patch
• Remove protective film from patch
• Apply one patch to the affected area of pain and leave in place for 8 to 12 hours
• If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
• Only use one patch at a time
• Do not use more than 2 patches per day
• Wash hands with soup and water after applying or removing patch
• Reseal pouch containing unused patches immediately after each use

OTHER SAFETY INFORMATION

OTHER INFORMATION:

• Some individuals may not experience pain relief until several minutes or hours after applying the patch
• Store in a cool, dry place
• Protect product from excessive moisture or sunlight
• Store at 67-77 °F (19-25 °C)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

Aloe Vera Gel, Arnica Extract, Boswellia Extract, Dihydroxyaluminum Aminoacetate, Dimethyl Sulfone, Glycerol, Methylparaben, Polyacrylic Acid, Polysorbate 80, Sodium Polyacryate, Sorbitol, Vitamin E, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DICLOCAINE 
lidocaine 4.5%, diclofenac 1.25% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53225-1095
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4.5 mg  in 100 mg
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)	DICLOFENAC SODIUM	1.25 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLYCERIN (UNII: PDC6A3C0OX)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53225-1095-1	1 mg in 1 POUCH; Type 0: Not a Combination Product	06/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/15/2022

Labeler - Terrain Pharmaceuticals (078358750)