OTC Medication Information: Icy Hot Pro Pain Relief Cream W/ Microbeads

ICY HOT PRO PAIN RELIEF CREAM W/ MICROBEADS- menthol and camphor (synthetic) 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.

ICY HOT PRO CREAM

Drug Facts

Active ingredient s

Purpose

Camphor 11%, Menthol 16%……………………………………………………………………………………………..Topical analgesic

Use s

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)

PRINCIPAL DISPLAY PANEL
IcyHot
Pro Pain Relief Cream
Net Wt 2 OZ (56 g)
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 0.16 g in 1 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 0.11 g in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
PROPANEDIOL
STEARETH-21
ALCOHOL
GLYCERYL MONOSTEARATE
CETOSTEARYL ALCOHOL
FARNESOL
STEARIC ACID
ALOE VERA LEAF
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
PENTYLENE GLYCOL
4-TERT-BUTYLCYCLOHEXANOL
POTASSIUM HYDROXIDE
ALLANTOIN
GRAPEFRUIT OIL
PEPPERMINT OIL
SPEARMINT OIL
JOJOBA OIL
MENTHYL LACTATE, (-)-
FERRIC FERROCYANIDE
DIISOPROPYL ADIPATE
DIETHYLENE GLYCOL MONOETHYL ETHER
GLYCERYL DILAURATE
POLYSORBATE 80
PEG-150 STEARATE
SOY STEROL
PHENOXYETHANOL
METHYLPARABEN
GLYCERIN
EDETATE DISODIUM ANHYDROUS
XANTHAN GUM
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0078-0 56 g in 1 TUBE None
2 NDC:41167-0078-2 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/21/2022
Labeler — Chattem, Inc. (003336013)

Revised: 08/2022 Chattem, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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