Diclocaine by Terrain Pharmaceuticals Diclocaine

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]

DICLOCAINE- lidocaine 4.5%, diclofenac 1.25% patch 
Terrain Pharmaceuticals

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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Diclocaine

Active Ingredients (in each patch):

Diclofenac Sodium (NSAID) 1.25% Arthritis Pain Reliever

Lidocaine 4.5% Topical Anesthetic

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:

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, 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.

Adults, or children over the age of 12:

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

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 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 INGREDIENTS:

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

Diclocaine

DICLOCAINE 
lidocaine 4.5%, diclofenac 1.25% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53225-1095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM1.25 mg  in 100 mg
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLYCERIN (UNII: PDC6A3C0OX)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53225-1095-11 mg in 1 POUCH; Type 0: Not a Combination Product06/15/202211/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/15/202211/01/2022
Labeler - Terrain Pharmaceuticals (078358750)

Revised: 11/2022