Capsaicin Patch
FDA Label NDC 69420-7025

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sa3, Llc for the product Capsaicin (NDC 69420-7025). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a physician:, keep out of reach of children and pets., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

  • Clean and dry the affected area.
  • Open pouch and remove one patch.
  • Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
  • Wash hands with soap and water after handling the patches.
  • Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
  • Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

    • Children under 18 years: Ask a physician

Other Information

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

Inactive Ingredients

Aqua (Deionized Water), Sodium Polyacrylate, Glycerin, Sorbitol, Sodium Cellulose Glycolate, Polysorbate 80, Lemon Oil, Aluminum Glycinate, Eucalyptus Oil, Methylparaben, EDTA Disodium Salt

Principal Display Panel

Capsaicin 0.025% Patch

NDC 69420-7025-1

10 Patches (5 per Resealable Pouch)

SA3, LLC

Principal Display Panelcapsaicin 0.025% Patchndc 69420-7025-110 Patches (5 Per Resealable Pouch)sa3, Llc (Capsaicin Patch 01)

Principal Display Panelcapsaicin 0.025% Patchndc 69420-7025-110 Patches (5 Per Resealable Pouch)sa3, Llc (Capsaicin Patch 01)

Principal Display Panelcapsaicin 0.025% Patchndc 69420-7025-110 Patches (5 Per Resealable Pouch)sa3, Llc (Capsaicin Patch 01)

Principal Display Panelcapsaicin 0.025% Patchndc 69420-7025-110 Patches (5 Per Resealable Pouch)sa3, Llc (Capsaicin Patch 01)

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