Drugplain

COLD AND HOT MEDICATED LARGE .05 g/g

Menthol · PATCH · Universal Distribution Center LLC

No Recall History
Plain English

COLD AND HOT MEDICATED LARGE is a patch containing menthol at .05 g/g, taken topical. Manufactured by Universal Distribution Center LLC.

Key Facts

Brand Name
COLD AND HOT MEDICATED LARGE
Generic Name
Menthol
NDC Code (Product)
52000-421
Manufacturer
Universal Distribution Center LLC
Strength
.05 g/g
Dosage Form
PATCH
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
11/25/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use92 reports
drug ineffective82 reports
dyspnoea82 reports
fatigue81 reports
pain75 reports
pruritus72 reports
dizziness65 reports
cough64 reports
headache63 reports
drug hypersensitivity58 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieve minor aches and pains of muscles and joints due to • simple backache • arthritis • muscle strains • bursitis • tendonitis • muscle sprains • bruises • cramps

Dosage & Administration

DIRECTIONS Adults and Children 12 years of age and older: • Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch • Should be used up to 8 hours • Should be used no more than 3 to 4 times daily Children under 12 years of age: Consult a doctor.

Warnings

WARNINGS: EXTERNAL USE ONLY When using this product • USE ONLY AS DIRECTED • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin. 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 • skin irritation develops If pregnant or breast-feeding , ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Frequently Asked Questions

What is COLD AND HOT MEDICATED LARGE used for?

COLD AND HOT MEDICATED LARGE contains Menthol. It is a patch taken topical. Consult your doctor for specific uses.

Is COLD AND HOT MEDICATED LARGE a controlled substance?

COLD AND HOT MEDICATED LARGE is not classified as a controlled substance by the DEA.

What is the generic name for COLD AND HOT MEDICATED LARGE?

The generic name for COLD AND HOT MEDICATED LARGE is Menthol. There are 12 other brand versions of Menthol.

What is the NDC code for COLD AND HOT MEDICATED LARGE .05 g/g?

The NDC (National Drug Code) for COLD AND HOT MEDICATED LARGE .05 g/g is 52000-421, listed by Universal Distribution Center LLC.