Label: WALGREENS COOL N HEAT DRY- lidocaine, menthol aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-9670-35 - Packager: Walgreens Co
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 10, 2021
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purposes
- Use
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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 doctorWhen 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 foldsStop 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 appliedExtremely 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.
- Directions
- Inactive ingredients
- Questions or comments? 1-888-577-8033
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SPL UNCLASSIFIED SECTION
Compare to Icy Hot® Lidocaine Plus Menthol Dry Spray active ingredients††
PAIN RELIEVING SPRAY
• CONTINUOUS SPRAY
MAXIMUM STRENGTH
NON - GREASY
• Temporarily relieves minor pain
• Dries instantly
DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED walgreens.com©2020 Walgreen Co.
††This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Icy Hot®.
- Packaging
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INGREDIENTS AND APPEARANCE
WALGREENS COOL N HEAT DRY
lidocaine, menthol aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9670 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOBUTANE (UNII: BXR49TP611) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9670-35 113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/09/2021 Labeler - Walgreens Co (008965063) Registrant - Strive Pharmaceuticals Inc. (080028013)
