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FDA LABEL GENERIC: Capsaicin MFR: Medcore LLC

Capsaicin 0.035 % Topical Cream

Drug Facts

Active ingredient

Capsaicin 0.035%

Purpose

External Analgesic

INDICATIONS AND USAGE

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

simple backache arthritis strains sprains

WARNINGS

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

Keep out of the reach of children.

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

On wounds or damaged skin
If you are allergic to capsicum or chili peppers

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 doctor if

Condition worsens or does not improve after regular use Severe burning persists or blistering occurs

DOSAGE AND ADMINISTRATION

Adults and children 18 years and older.

Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily children under 18years:ask a doctor

excursions permitted to 15-30C(59-86F).
See USP Controlled Room Temperature.

Poly(acrylic acid) solution, Polysorbate 80, Glycerin, polyethylene glycol-400, Sodium polyacrylate, SORBITOL, Carboxymethyl Cellulose Sodium, aluminium magnesium silicate, PHENOXYETHANOL, EDTA Disodium salt, Lemon oil, Water, Peppermint oil

ASK A DOCTOR

NDC: 82461-417-10

Medcore LLC

Capsaicin 0.035% cream

100ml

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269