FDA Label for Rematex
View Indications, Usage & Precautions
Rematex Product Label
The following document was submitted to the FDA by the labeler of this product Home Aide Diagnostics, Inc.. 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.
Package Label.Principal Display Panel
Otc - Purpose
PURPOSE: Topical analgesic
Otc - Active Ingredient
ACTIVE INGREDIENTS
Histamine Dihydrochloride 0.035% ---------------------------------------------------------------------------------Topical analgesic
Menthol 3% --------------------------------------------------------------------------------------------------------- Topical analgesic
Capsaicin 0.0375% ------------------------------------------------------------------------------------------------- Topical analgesic
Indications & Usage
INDICATIONS
For the temporary relief of minor pain of muscles and joints associated with:
- Arthritis
- Simple Backache
- Strains
- Sprains
- Bruises
Warnings
WARNINGS
FOR EXTERNAL USE ONLY
.
- Use only as directed
- Do not bandage tightly
- Do not use with a heating pad
- Avoid contact with the eyes or mucous membranes
- Do not apply to wounds, damaged, broken or irritated skin
- A transient burning sensation may occur upon application but generally disappears in several days
- If severe burning sensation occurs, discontinue use immediately and call a doctor
- Do not expose the area treated with product to heat or direct sunlight
Dosage & Administration
DIRECTIONS
- Adults and children over 18 years:
- Apply generously to affected area
- Massage into painful area until thoroughly absorbed into skin
- Repeat as necessary, not more than 3-4 times daily.
- Wash hands with soap and water immediately after use.
- Children 18 years or younger: ask a doctor
- Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.
Otc - Stop Use
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
- Redness is present or irritation develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Otc - Pregnancy Or Breast Feeding
If pregnant of breast-feeding, ask a healthcare professional before use
Inactive Ingredient
INACTIVE INGREDIENTS
aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose Sodium; water;
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