Walgreens Cool N Heat Dry
FDA Label NDC 0363-9670
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co for the product Walgreens Cool N Heat Dry (NDC 0363-9670). 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, purposes, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lidocaine 4%
Menthol 1%
Purposes
Topical anesthetic
Topical analgesic
Use
temporarily relieves minor pain
Warnings
For external use only
Do not use • on large areas of the body or on cut, irritated or swollen skin
• on puncture wounds • for more than one week without consulting a doctor
When using this product
• use only as directed. Read and follow all directions and warnings on this label.
• do not allow contact with the eyes and mucous membranes
• rare cases of serious burns have been reported with products of this type
• do not apply to wounds or damaged, broken or irritated skin
• avoid spraying on face • avoid inhalation of spray
• do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
• do not use at the same time as other topical analgesics
• a transient burning sensation may occur upon application but generally disappears in several days
• avoid applying into skin folds
Stop use and ask a doctor if • condition worsens • redness is present • irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Extremely Flammable • do not use near heat or flame or while smoking
• avoid long term storage above 104°F (40°C) • do not puncture or incinerate. Contents under pressure.
• do not store at temperatures above 120°F (49°C)
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 right away.
Directions
adults and children over 12 years:
• spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
• product will dry quickly on its own, and does not need to be rubbed in
children 12 years or younger: ask a doctor
Inactive Ingredients
caprylic/capric triglyceride, isobutane, propylene glycol, SD alcohol 40B (30%)
Packaging
Spray1 (0363920035 3)
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