Label: COOL N HEAT LIDOCAINE DRY- lidocaine and menthol, unspecified form spray
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-850-04 - Packager: TOPCO ASSOCIATES LLC
- 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 March 8, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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 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
- Directions
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 113 g Can Label
NDC 36800-908-35
TopCare
health®COMPARE TO ICY HOT® LIDOCAINE PLUS
MENTHOL DRY SPRAY ACTIVE INGREDIENTS*MAXIMUM STRENGTH
Cool n' Heat
Dry Spray
Pain Relief
with Lidocaine + MentholLIDOCAINE 4% / TOPICAL ANESTHETIC
MENTHOL 1% / TOPICAL ANALGESIC•OUR PHARMACISTS•
RECOMMENDCONTINUOUS SPRAY
- Temporarily Numbs
Pain Away - Dries Instantly
- Non-Greasy
✓QUALITY
GUARANTEEDNET WT 4 OZ (113 g)
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call 1-888-423-0139 - Temporarily Numbs
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INGREDIENTS AND APPEARANCE
COOL N HEAT LIDOCAINE DRY
lidocaine and menthol, unspecified form sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-850 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10 mg in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOBUTANE (UNII: BXR49TP611) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-850-04 113 g in 1 CAN; Type 0: Not a Combination Product 05/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 05/01/2021 Labeler - TOPCO ASSOCIATES LLC (006935977)