Otc - Active Ingredient
Active ingredients Purposes
Camphor 4%...................................Topical analgesic
Menthol 10%...................................Topical analgesic
Methyl salicylate 30%......................Topical analgesic
Xray Dol Cream
FDA Label NDC 50066-454
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa, Inc. for the product Xray Dol (NDC 50066-454). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- temporarily relieves the minor aches and pains of muscles and joints associated with
- sprains
- simple backache
- arthritis
- strains
- bruises
Warnings
Warnings
For external use only
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Otc - Do Not Use
Do not use
- on wounds or damaged skin
- with a heating pad
- on a child under 12 years of age with arthritis-like conditions
Otc - Ask Doctor
Ask a doctor before use if you have redness over the affected area.
Otc - When Using
When using this product
- do not use otherwise than as directed
- avoid contain with the eyes, mucous membranes or rashes
- do not bandage tightly
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
- use only as directed
- adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
Storage And Handling
Other information
store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid
Dosage & Administration
Distributed by
Genomma Lab USA, Inc.
Made in China
Package Label.Principal Display Panel
6454 (6454.1)
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