ICY HOT PRO PAIN MASSAGING BALM- camphor and menthol cream

Icy Hot Pro Pain Massaging Balm by

Drug Labeling and Warnings

Icy Hot Pro Pain Massaging Balm by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Icy Hot PRO Pain Relief Massaging Balm

Drug Facts

Active ingredient                                                

Camphor 11% 

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

• arthritis
  
• simple backache
  
• strains
  
• sprains
  
• bruises

Warnings

For external use only

Do not use

• on wounds or on irritated or damaged skin
  
• with a heating pad

When using this product

• use only as directed
  
• do not bandage tightly
  
• avoid contact with eyes and mucous membranes
  
• do not expose the area to local heat or direct sunlight
  
• rare cases of serious burns have been reported with products of this type
  
• 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 or symptoms persist for more than 7 days
  
• symptoms clear up and occur again within a few days
  
• redness is present or excessive skin irritation occurs
  
• you experience severe burning pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children. 

This product is not a toy or intended for use by children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and older:
  • massage into affected area using the no-mess balm not more than 3 to 4 times daily
    
  • wash hands thoroughly with soap and water if product comes in contact with hands
  
  
• children under 12 years of age: ask a doctor

Inactive ingredients

prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed wax, theobroma cacao (cocoa) seed butter, cocos nucifera (coconut) oil, persea gratissima (avocado) oil, hydrogenated vegetable oil, copernicia cerifera (carnauba) wax, synthetic beeswax, citrus paradisi (grapefruit) peel oil, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil

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

Keep carton as it contains important information. 

     

PRINCIPAL DISPLAY PANEL

ICY HOT Pro Pain Relief

Massaging Balm
NET WT 1.25 OZ (35 g)

INGREDIENTS AND APPEARANCE

ICY HOT PRO PAIN MASSAGING BALM 
camphor and menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0790
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.16 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	.11 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
COCOA BUTTER (UNII: 512OYT1CRR)
COCONUT OIL (UNII: Q9L0O73W7L)
AVOCADO OIL (UNII: 6VNO72PFC1)
HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
GRAPEFRUIT OIL (UNII: YR377U58W9)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)
SPEARMINT OIL (UNII: C3M81465G5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0790-0	1 in 1 CARTON	01/15/2024
1		35 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/15/2024

Labeler - Chattem, Inc. (003336013)