ICY HOT NATURALS- menthol cream 
Chattem, Inc.

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.

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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)

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.075 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAPSAICIN (UNII: S07O44R1ZM)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
TEA LEAF (UNII: GH42T47V24)  
SPEARMINT (UNII: J7I2T6IV1N)  
FRUIT (UNII: C2AIY4ERZC)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPANEDIOL (UNII: 5965N8W85T)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0093-81 in 1 CARTON12/01/201010/14/2019
170.8 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:41167-0093-62.8 g in 1 POUCH; Type 0: Not a Combination Product12/01/201010/14/2019
3NDC:41167-0093-714.1 g in 1 TUBE; Type 0: Not a Combination Product12/01/201010/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/201010/14/2019
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 1003336013MANUFACTURE(41167-0093)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 2830410721MANUFACTURE(41167-0093)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services557434805PACK(41167-0093)

Revised: 10/2019
Document Id: 6b05e643-ae79-4147-a238-96226e2f2d81
Set id: 7de3f2ec-753b-49f7-a53c-935eb5069911
Version: 2
Effective Time: 20191014
 
Chattem, Inc.