Capsaicin Patch

Capsaicin Patch
SPL v4
SPL
SPL Set ID 030d67b2-d798-4134-bc96-69536ad46f2d
Route
TOPICAL
Published
Effective Date 2024-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Water Sodium Polyacrylate (8000 Mw) Glycerin Sorbitol Carboxymethylcellulose Sodium, Unspecified Form Polysorbate 80 Lemon Oil Dihydroxyaluminum Aminoacetate Anhydrous Eucalyptus Oil Methylparaben Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-08

Description

CAPSAICIN – Capsaicin 0.025% Patch Alexso, Inc. 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. ---------- Capsaicin 0.025% Patch Drug Facts

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

CAPSAICIN – Capsaicin 0.025% Patch Alexso, Inc. 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. ---------- Capsaicin 0.025% Patch Drug Facts

Whe

• 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

Uses

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

• arthritis

• simple backache

• strains

• bruises

• sprains

Section 42229-5

CAPSAICIN – Capsaicin 0.025% Patch

Alexso, Inc.

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.

----------

Capsaicin 0.025% Patch



Drug Facts


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.

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

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.

Stop Use and As

• 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

Active Ingredient

Capsaicin 0.025%

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 50488-2025-1

10 Patches (5 per Resealable Pouch)

Alexso, Inc

Keep Out of Reach of Children

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


Structured Label Content

Whe

• 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

Uses

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

• arthritis

• simple backache

• strains

• bruises

• sprains

Section 42229-5 (42229-5)

CAPSAICIN – Capsaicin 0.025% Patch

Alexso, Inc.

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.

----------

Capsaicin 0.025% Patch



Drug Facts


Purpose

External analgesic

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.

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

Do Not Use (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.

Stop Use and As (Stop use and as)

• 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

Active Ingredient (Active ingredient)

Capsaicin 0.025%

Other Information (Other information)

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

Inactive Ingredients (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 (PRINCIPAL DISPLAY PANEL)

Capsaicin 0.025 %   Patch

NDC 50488-2025-1

10 Patches (5 per Resealable Pouch)

Alexso, Inc

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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