frankie avalon's zero pain roll-on pain reliever

frankie avalon's zero pain roll-on pain reliever
SPL v1
SPL
SPL Set ID e32acb5f-5bc3-4228-b037-6315d080f556
Route
topical
Published
Effective Date 2024-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
capsaicin (0.25 mg)
Inactive Ingredients
aloe vera leaf water arnica montana flower indian frankincense c13-14 isoparaffin chamomile black cohosh dmdm hydantoin glycerin goldenseal isopropyl alcohol laureth-7 medicago sativa whole polysorbate 20 yucca schidigera whole

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-06

Description

Capsaicin 0.025%


Medication Information

Description

Capsaicin 0.025%

Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Section 55105-1

External Analgesic

Warnings:

For external use only. Avoid contact with the eyes. 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 doctor. Do not apply to wounds or damaged skin. Do not bandage tightly.

Directions:

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Drug Facts:

Active Ingredient

Capsaicin 0.025%

Package Labeling:

Other Information:

Products containing capsaicin may cause a burning, stinging or tingling sensation where applied. This is a natural reaction and varies with each individual and usually decreases or disappears after continued use. Read all information on the box and the opposite panel before use.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Boswella Serrata Extract, C13-14 Isoparaffin, Chamomilla Recutitta (Chamomile) Extract, Cimicifuga Racemosa (Black Cohosh) Extract, DMDM Hydantoin, Glycerin, Hydrastis Canadensis (Goldenseal) Root Extract, Isopropyl Alcohol, Laureth-7, Medicago Sativa (Alfalfa) Extract, Polyacrylamide, Polysorbate-20, Yucca Schidegera Extract. 

Keep Out of Reach of Children


Structured Label Content

Uses: (USES:)

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Section 55105-1 (55105-1)

External Analgesic

Warnings: (WARNINGS:)

For external use only. Avoid contact with the eyes. 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 doctor. Do not apply to wounds or damaged skin. Do not bandage tightly.

Directions: (DIRECTIONS:)

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Drug Facts: (DRUG FACTS:)

Active Ingredient

Capsaicin 0.025%

Package Labeling:

Other Information: (OTHER INFORMATION:)

Products containing capsaicin may cause a burning, stinging or tingling sensation where applied. This is a natural reaction and varies with each individual and usually decreases or disappears after continued use. Read all information on the box and the opposite panel before use.

Other Ingredients: (OTHER INGREDIENTS:)

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Boswella Serrata Extract, C13-14 Isoparaffin, Chamomilla Recutitta (Chamomile) Extract, Cimicifuga Racemosa (Black Cohosh) Extract, DMDM Hydantoin, Glycerin, Hydrastis Canadensis (Goldenseal) Root Extract, Isopropyl Alcohol, Laureth-7, Medicago Sativa (Alfalfa) Extract, Polyacrylamide, Polysorbate-20, Yucca Schidegera Extract. 

Keep Out of Reach of Children


Advanced Ingredient Data


Raw Label Data

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