CAPSAICIN 0.1 PERCENT- capsaicin cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)

Available from:

Alexso, Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

External analgesic Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

CAPSAICIN 0.1 PERCENT- CAPSAICIN CREAM
ALEXSO, INC
_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 CREAM
CAPSAICIN – CAPSAICIN 0.1% CREAM
ALEXSO, INC.
_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 0.1% CREAM
_DRUG FACTS_
ACTIVE INGREDIENT
Capsaicin 0.1%
PURPOSE
External analgesic
USES
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.
DO NOT USE
• 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
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
immediately.
DIRECTIONS
ADULTS AND CHILDREN 18 YEARS OF AGE 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 18 YEARS: Ask a doctor
OTHER INFORMATION
Store at room temperature 15°-30°C (59°-86°F)
INACTIVE INGRED