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Icy hot vanishing scent - Medication Information

Product NDC Code 41167-0092
Drug Name

Icy hot vanishing scent

Type Brand
Active Ingredients
Menthol .025 g/g
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 282805
Application Number M017
Labeler Name Chattem, Inc.
Packages
Package NDC Code Description
41167-0092-0 1 tube in 1 carton (41167-0092-0) / 71 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Menthol 2.5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions adults and children over 12 years: apply generously to affected area squeeze desired amount of Icy Hot ® pain relieving gel onto affected area using the sponge-top applicator, massage dispensed gel into painful area until thoroughly absorbed repeat as necessary, but not more than 4 times daily children 12 years or younger: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients alcohol denat. (15%), allantoin, aloe barbadensis leaf juice, carbomer, DMDM hydantoin, glycerin, methylparaben, phenoxyethanol, propylparaben, steareth-2, steareth-21, triethanolamine, water Keep carton as it contains important information. Close cap tightly after use.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Purpose

Information about the drug product’s indications for use.
Purpose Topical analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Icy Hot Vanishing Scent Menthol MENTHOL MENTHOL ALCOHOL ALLANTOIN ALOE VERA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE DMDM HYDANTOIN GLYCERIN METHYLPARABEN PHENOXYETHANOL PROPYLPARABEN STEARETH-2 STEARETH-21 TROLAMINE WATER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL MENTHOL 2.5% NEW LOOK ICYHOT ® ORIGINAL VANISHING SCENT PAIN RELIEVING GEL Net wt 2.5 oz (70.8 g) MENTHOL 2.5% NEW LOOK ICYHOT® ORIGINAL VANISHING SCENT PAIN RELIEVING GEL Net wt 2.5 oz (70.8 g)

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product ■ use only as directed. Read and follow all directions and warnings on this carton. ■ avoid contact with 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 ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ a transient burning sensation may occur upon application but generally disappears in several days ■ avoid applying into skin folds

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health care professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only When using this product ■ use only as directed. Read and follow all directions and warnings on this carton. ■ avoid contact with 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 ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ 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 If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API