Icy Hot Naturals

Drug Labeling and Warnings

Drug Details [pdf]

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)

ICY HOT NATURALS 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0093
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.075 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0093-8	1 in 1 CARTON	12/01/2010	10/14/2019
1		70.8 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-0093-6	2.8 g in 1 POUCH; Type 0: Not a Combination Product	12/01/2010	10/14/2019
3	NDC: 41167-0093-7	14.1 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2010	10/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	12/01/2010	10/14/2019

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 1		003336013	MANUFACTURE(41167-0093)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	MANUFACTURE(41167-0093)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services		557434805	PACK(41167-0093)

Revised: 10/2019

Document Id: 6b05e643-ae79-4147-a238-96226e2f2d81

34390-5

Set id: 7de3f2ec-753b-49f7-a53c-935eb5069911

Version: 2

Effective Time: 20191014