ICY HOT VANISHING SCENT- menthol gel

Icy Hot Vanishing Scent by

Drug Labeling and Warnings

Icy Hot Vanishing Scent by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., CHATTEM, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 2.5%

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 or mucous membranes
  
• do not apply to wounds or damaged, broken or irritated skin

Stop use and ask a doctor if

• condition worsens
  
• symptoms persist for more than 7 days or clear up and occur again within a few days
  
• redness is present
  
• irritation develops

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.

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 ingredients

allantoin, aloe barbadensis leaf juice, carbomer, DMDM hydantoin, glycerin, methylparaben, phenoxyethanol, propylparaben, SD alcohol 40-2 (15.47%), steareth-2, steareth-21, triethanolamine, water (245-135)

Keep carton as it contains important information.

Close cap tightly after use.

PRINCIPAL DISPLAY PANEL

ICYHOT® VANISHING SCENT PAIN RELIEVING GEL
Menthol 2.5%
Net wt 2.5 oz (70.8 g)

INGREDIENTS AND APPEARANCE

ICY HOT VANISHING SCENT 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0092
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.025 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0092-0	1 in 1 CARTON	03/01/2007
1		71 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	03/01/2007

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 1		003336013	MANUFACTURE(41167-0092)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	MANUFACTURE(41167-0092)