Capsadyn

Capsadyn
SPL v1
SPL
SPL Set ID 07731045-0d2b-76b7-e063-6294a90af921
Route
TOPICAL
Published
Effective Date 2023-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.25 g)
Inactive Ingredients
Polysorbate 80 Phenoxyethanol Stearic Acid Coconut Oil Ethylhexylglycerin Glyceryl Monostearate Polyoxyl 20 Cetostearyl Ether Glycerin Water Myristyl Myristate Shea Butter Sunflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-13

Description

Topical analgesic


Medication Information

Warnings and Precautions

For external use only.

Do not apply to wounds and damaged skin.

When using this product use only as directed, temporary warming of skin may be experienced after application, avoid contact with eyes or mucous membranes, do not bandage tightly, do not expose the treated area to heat, and avoid activity that may cause perspiration.

Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, muscle strains, sprains, bruises, related muscle injuries, and simple backache. Provides penetrating pain relief.

Dosage and Administration

Adults and children 18 years of age and older:

apply to affected areas not more than 3-4 times daily, rub in the cream until completely absorbed, the amount used depends on the depth of the pain, typically provides pain relief without any noticeable warming or cooling, wash hands thoroughly with soap and water after applying.

Children under 18 years of age: consult a doctor.

Description

Topical analgesic

Section 50565-1

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

Section 51727-6

Butyrospermum parkii (shea) butter, ceteareth-20, cetyl alcohol, cocos nucifera (coconut) oil, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, myristyl myristate, phenoxyethanol, polysorbate 20, stearic acid, water.

Section 51945-4

Section 55105-1

Topical analgesic

Section 55106-9

Capsaicin 0.25% as Capsaicin palmitate


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, muscle strains, sprains, bruises, related muscle injuries, and simple backache. Provides penetrating pain relief.

Dosage and Administration (34068-7)

Adults and children 18 years of age and older:

apply to affected areas not more than 3-4 times daily, rub in the cream until completely absorbed, the amount used depends on the depth of the pain, typically provides pain relief without any noticeable warming or cooling, wash hands thoroughly with soap and water after applying.

Children under 18 years of age: consult a doctor.

Warnings and Precautions (34071-1)

For external use only.

Do not apply to wounds and damaged skin.

When using this product use only as directed, temporary warming of skin may be experienced after application, avoid contact with eyes or mucous membranes, do not bandage tightly, do not expose the treated area to heat, and avoid activity that may cause perspiration.

Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Butyrospermum parkii (shea) butter, ceteareth-20, cetyl alcohol, cocos nucifera (coconut) oil, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, myristyl myristate, phenoxyethanol, polysorbate 20, stearic acid, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Capsaicin 0.25% as Capsaicin palmitate


Advanced Ingredient Data


Raw Label Data

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