ICY HOT PRO PAIN RELIEF CREAM W/ MICROBEADS- menthol, camphor cream

Icy Hot Pro Pain Relief Cream w/ microbeads by

Drug Labeling and Warnings

Icy Hot Pro Pain Relief Cream w/ microbeads 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 CREAM

Drug Facts

Active ingredients

Purpose

Camphor 11%, Menthol 16%...........................................................................................................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.

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

Directions

• adults and children 12 years of age and older:
  ▪ apply a thin layer to affected area not more than 3 to 4 times daily
  ▪ massage until thoroughly absorbed into skin
  ▪ wash hands thoroughly with soap and water after each use
  
• children under 12 years of age: ask a doctor

Inactive ingredients

 

water, propanediol, steareth-21, alcohol denat., glyceryl stearate, cetyl alcohol, farnesol, stearic acid, aloe barbadensis leaf juice, acrylates/C10-30 alkyl acrylate crosspolymer, menthyl lactate, jojoba esters, diisopropyl adipate, pentylene glycol, 4-t-butylcyclohexanol, potassium hydroxide, allantoin, fragrance, citrus paradisi (grapefruit) peel oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil, ethoxydiglycol, glyceryl dilaurate, polysorbate 80, PEG-150 stearate, glycine soja (soybean) sterols, phenoxyethanol, methylparaben, glycerin, disodium EDTA, xanthan gum, ferric ferrocyanide, citric acid

357-102

Close cap tightly after use.

Keep carton as it contains important information.

PRINCIPAL DISPLAY PANEL

IcyHot
Pro Pain Relief Cream
Net Wt 2 OZ (56 g)

INGREDIENTS AND APPEARANCE

ICY HOT PRO PAIN RELIEF CREAM W/ MICROBEADS 
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.16 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.11 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
STEARETH-21 (UNII: 53J3F32P58)
ALCOHOL (UNII: 3K9958V90M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FARNESOL (UNII: EB41QIU6JL)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ALLANTOIN (UNII: 344S277G0Z)
GRAPEFRUIT OIL (UNII: YR377U58W9)
PEPPERMINT OIL (UNII: AV092KU4JH)
SPEARMINT OIL (UNII: C3M81465G5)
JOJOBA OIL (UNII: 724GKU717M)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
FERRIC FERROCYANIDE (UNII: TLE294X33A)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PEG-150 STEARATE (UNII: 7BSG7DF10Q)
SOY STEROL (UNII: PL360EPO9J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0078-0	56 g in 1 TUBE; Type 0: Not a Combination Product	02/21/2022
2	NDC: 41167-0078-2	28 g in 1 TUBE; Type 0: Not a Combination Product	06/12/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/21/2022

Labeler - Chattem, Inc. (003336013)