Rite Aid Roll-on
FDA Label NDC 76168-313
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma Llc for the product Rite Aid Roll-on (NDC 76168-313). 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 drug facts, active ingredients, purpose, uses:, warnings:, flammable:, ask a doctor before use if you have:, when using this product:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Menthol USP 4%
Purpose
Cooling Pain Relief
Uses:
Temporary relief from minor aches and pains of sore muscles and joints associated with: - arthritis, - backache, - strains, - sprains
Warnings:
For external use only
Flammable:
Keep away from excessive heat or open flame
Ask A Doctor Before Use If You Have:
Sensitive skin
When Using This Product:
- Avoid contact with eyes or mucous membranes
- Do not apply to wounds or damaged skin.
- Do not use with other ointments, creams, sprays, or liniments.
- Do not apply to irritated skin or if excessive skin irritation develops.
- Do not bandage
- Wash hands after use with cool water
- Do not use with heating pad or device.
Stop Use And Ask A Doctor If:
Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur
If Pregnant Or Breast-Feeding:
Ask a health professional before use
Keep Out Of Reach Of Children:
If accidentally ingested, get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
Children under 2 years of age: Consult physician
Inactive Ingredients:
Aloe Vera gel, Camphor, Carbomer, FD&C blue 1, FD&C yellow 5 Glycerol, Isopropyl Alcohol, Ispropyl Myristate, Purified water, Silica, triethanolamine, Tocopheryl (Vitamin E) Acetate,
Other Information:
Store in a cool dry place with lid closed tightly
Questions Or Comments
1-855-314-1850
Package Label.Principal Display Panel
Ra_cold-therapy-roll-on_2.5 (Ra Cold Therapy Roll On 2.5)
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