Icy Hot Naturals

Dosage form: cream
Ingredients: MENTHOL 0.075g in 1g
Labeler: Chattem, Inc.
NDC Code: 41167-0093

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.

Icy Hot Naturals

Drug Facts

Active ingredient

Menthol 7.5%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

For 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, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight

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

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 right away.

Directions

adults and children over 1 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

children 12 years or younger: ask a doctor

Inactive ingredients

aloe barbadensis leaf juice, beeswax, benzyl alcohol, capsaicin, cetearyl alcohol, cetyl alcohol, cetyl esters, cetyl palmitate, citrus paradise (grapefruit) peel oil, di-PEG-2 soyamine IPDI, disodium EDTA, distearyldimonium chloride, eucalyptus globules leaf oil, glycerin, hydrogenated olive oil, jojoba esters, melaleuca alternifolia (tea tree) leaf oil, menthe viridis (spearmint) leaf oil, olea europaea (olive) fruit oil, olea europaea (olive) oil unsaponifiables, polysorbate 60, potassium hydroxide, propanediol, sorbitan olivate, sorbitan palmitate, steareth-2, steareth-21, stearyl alcohol, water (283-109)

Close cap tightly after use. Keep carton as it contains important information about this product.

PRINCIPAL DISPLAY PANEL

ICYHOT® NATURALS
pain relief cream
MENTHOL 7.5%
Net wt 2.5 oz (70.8 g)

ICY HOT NATURALS 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0093
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.075 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
YELLOW WAX 
BENZYL ALCOHOL 
CAPSAICIN 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
CETYL ESTERS WAX 
CETYL PALMITATE 
GRAPEFRUIT PEEL 
EDETATE DISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
CORYMBIA CITRIODORA LEAF OIL 
GLYCERIN 
OLIVE OIL 
TEA LEAF 
SPEARMINT 
FRUIT 
POLYSORBATE 60 
POTASSIUM HYDROXIDE 
PROPANEDIOL 
SORBITAN OLIVATE 
SORBITAN MONOPALMITATE 
STEARETH-2 
STEARETH-21 
STEARYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:41167-0093-81 TUBE (1 TUBE) in 1 CARTON
170.8 g in 1 TUBE
2NDC:41167-0093-62.8 g in 1 POUCH
3NDC:41167-0093-714.1 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/2010
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Chattem Plant 1003336013MANUFACTURE
Establishment
NameAddressID/FEIOperations
Chattem Plant 2830410721MANUFACTURE
Establishment
NameAddressID/FEIOperations
Span Packaging Services557434805PACK

Revised: 03/2011
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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