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NDC 69420-7025-01 Capsaicin 0.025 g/100g Details

Capsaicin 0.025 g/100g

Capsaicin is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by SA3, LLC. The primary component is CAPSAICIN.

MedlinePlus Drug Summary

Nonprescription (over-the-counter) capsaicin patches (Aspercreme Warming, Salonpas Pain Relieving Hot, others) are used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Prescription capsaicin patches (Qutenza) are used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Prescription capsaicin patches (Qutenza) are also used to relieve the pain of diabetic neuropathy (numbness or tingling due to nerve damage in people who have diabetes). Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.

Related Packages: 69420-7025-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Capsaicin Transdermal Patch

Product Information

NDC	69420-7025
Product ID	69420-7025_02a6e5f4-9757-449d-bb9f-7bb2ac22439a
Associated GPIs	90850025005920
GCN Sequence Number	022813
GCN Sequence Number Description	capsaicin ADH. PATCH 0.025 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	33562
HICL Sequence Number	002577
HICL Sequence Number Description	CAPSAICIN
Brand/Generic	Generic
Proprietary Name	Capsaicin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Capsaicin
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	0.025
Active Ingredient Units	g/100g
Substance Name	CAPSAICIN
Labeler Name	SA3, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69420-7025-01 (69420702501)

Pricing Information	N/A
NDC Package Code	69420-7025-1
Billing NDC	69420702501
Package	10 PATCH in 1 CARTON (69420-7025-1) / 100 g in 1 PATCH
Marketing Start Date	2021-06-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7950aabc-4724-4add-a96e-62ab7e75d4fc Details

SPL UNCLASSIFIED SECTION

CAPSAICIN – Capsaicin 0.025% Patch

SA3, LLC

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.

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)