FDA Label for Capsaicin
View Indications, Usage & Precautions
Capsaicin Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient Purpose
Capsaicin 0.1%....................................................Topical analgesic
Otc - Purpose
Uses
- temporarily relieves minor pain of muscles and joints associated with:
- arthritis
- simple backache
- strains
- sprains
- bruises
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- on wounds, damaged, broken or irritated skin
- with a heating pad
- if you are allergic to capsicum or chili peppers
Otc - When Using
When using this product
- avoid contact with the eyes or mucous membranes
- do not bandage tightly
- a transient burning sensation may occur upon application but generally disappears in several days
- do not expose the treated area to heat or direct sunlight
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present or irriration develops
- a severe burning sensation occurs
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
- adults and children 18 years of age and older:
- use only as directed
- apply to affected area
- massage into painful area until thoroughly absorbed
- repeat as necessary, but no more than 3 to 4 times daily
- wash hands with soap and water after applying
- children under 18 years of age: ask a doctor
Storage And Handling
Other information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactivate ingredients
benzyl alcohol, cetyl alcohol, isopropyl myristate, petrolatum, polyoxyl 40 stearate, purified water, sorbitan monostearate, sorbital
Dosage & Administration
Distributed by:
Rite Aid
30 Hunter Lane
Camp Hill, PA 17011
Made in China
Package Label.Principal Display Panel
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