Capsaicin Cream

Capsaicin Cream
SPL v3
SPL
SPL Set ID 5617e91d-e650-4a0d-8565-b8288ea41c77
Route
TOPICAL
Published
Effective Date 2024-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Water Arnica Montana Flower Indian Frankincense Cetostearyl Alcohol Ethylhexylglycerin Glucosamine Sulfate Glycerin Glyceryl Monostearate C13-14 Isoparaffin Isostearyl Palmitate Laureth-7 Dimethyl Sulfone Peg-100 Stearate Phenoxyethanol Propylene Glycol Stearic Acid Trolamine Chondroitin Sulfate (bovine) Polyacrylamide (10000 Mw) Sodium Polyacrylate (2500000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-11

Description

CAPSAICIN – Capsaicin 0.025% Cream 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. ---------- Capsaicin 0.025% Cream Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

CAPSAICIN – Capsaicin 0.025% Cream 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. ---------- Capsaicin 0.025% Cream 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:

• simple backache

• arthritis

• strains

• sprains

Do Not

• Apply to wounds or damaged skin

• Bandage tightly

• If you are allergic to capsicum or chili peppers

Section 42229-5

CAPSAICIN – Capsaicin 0.025% Cream

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.

----------

Capsaicin 0.025% Cream



Drug Facts


Warnings

For external use only

Read all warnings and directions before use. Test first on small area of skin.

Directions

Adults and children 2   years of age and older:

Apply to affected area not more than 3 to 4 times daily. Wash hands thoroughly with soap and water immediately after application.

Children under 2 years : consult a doctor

Stop Use and As

• Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

• Severe burning persists or blistering occurs

Active Ingredient

Capsaicin 0.025%

Other Information

Store at room temperature 15°-30°C (59°-86°F). Protect the product from excessive heat and direct sun.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine

Principal Display Panel

Capsaicin 0.025% cream

NDC 69420-6025-5

50 grams

SA3, LLC

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional before use.


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:

• simple backache

• arthritis

• strains

• sprains

Do Not (Do not)

• Apply to wounds or damaged skin

• Bandage tightly

• If you are allergic to capsicum or chili peppers

Section 42229-5 (42229-5)

CAPSAICIN – Capsaicin 0.025% Cream

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.

----------

Capsaicin 0.025% Cream



Drug Facts


Purpose

Topical analgesic

Warnings

For external use only

Read all warnings and directions before use. Test first on small area of skin.

Directions

Adults and children 2   years of age and older:

Apply to affected area not more than 3 to 4 times daily. Wash hands thoroughly with soap and water immediately after application.

Children under 2 years : consult a doctor

Stop Use and As (Stop use and as)

• Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

• 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). Protect the product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Capsaicin 0.025% cream

NDC 69420-6025-5

50 grams

SA3, LLC

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

If swallowed, get medical help or contact a Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)