CAPSAICIN- capsaicin patch 
FORREAL PHARMACEUTICALS LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Capsaicin Patch

CAPSAICIN – Capsaicin 0.025% Patch

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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Capsaicin 0.025% Patch


Drug Facts

Active ingredient

Capsaicin 0.025%

Purpose

External analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

• arthritis

• simple backache

• strains

• bruises

• sprains

Warnings

For external use only. Use only as directed or as directed by a health care professional

Read all warnings and directions before use.

Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.

Do not use

• On wounds, cuts, damaged or infected skin

• On eyes, mouth, genitals, or any other mucous membranes

Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.

When using this product

• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.

• Avoid contact with the eyes, lips, nose and mucous membranes

• Do not tightly wrap or bandage the treated area

• Do not apply heat to the treated area immediately before or after use

Stop use and ask a physician:

• If pregnant or breast feeding

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

• If severe burning persists or blistering occurs

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 18 years of age and older:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

Children under 18 years: Ask a physician

Other information

Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

Glycerin, Sodium polyacrylate, Dihydroxyaluminum aminoacetate, Edetate disodium, Kaolin, Carboxymethylcellulose sodium, Titanium dioxide, L-Tartaric acid, Polyacrylic acid, Capsaicin, Propylene glycol, Polysorbate 80, Petrolatum, Hydroxyacetophenone, Water, PVP

PRINCIPAL DISPLAY PANEL

NDC 81877-515-15

Qty: 15 Patches
(5 per Resealable Pouch) x 3

Capsaicin 0.025%
Topical Pain Patch
for temporary pain relief

Forreal Pharmaceuticals LLC

PRINCIPAL DISPLAY PANEL

CAPSAICIN 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-515
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
KAOLIN (UNII: 24H4NWX5CO)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TARTARIC ACID (UNII: W4888I119H)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PETROLATUM (UNII: 4T6H12BN9U)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81877-515-1515 in 1 CARTON08/16/2022
1100 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/16/2022
Labeler - FORREAL PHARMACEUTICALS LLC (118029197)

Revised: 8/2022
Document Id: 2dd4f30e-a3be-4ce2-a40c-97177eb46adc
Set id: e4d301fd-74d6-4312-9049-3ee1564f2bbb
Version: 2
Effective Time: 20220830
 
FORREAL PHARMACEUTICALS LLC