OTC Medication Information: Icy Hot Advanced Relief

ICY HOT ADVANCED RELIEF- camphor (synthetic) and menthol cream
Chattem, Inc.

Drug Facts

Active i ngredient s

Menthol 16%

Camphor 11%

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, or medicated patch
  • 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 within a few days

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 of 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

a dults and children over 12 years:

  • apply a thin layer to affected area

  • message into painful area until thoroughly absorbed into skin

  • repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications

  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

Children 12 years and younger: ask a doctor

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice, cetyl alcohol, diisopropyl adipate, disodium EDTA, ethoxydiglycol, fragrance, glycerin, glyceryl stearate, menthyl lactate, methylparaben, PEG-150 sterate, pentylene glycol, 4-t-butylcyclohexanol, phenoxyethanol, polysorbate 80, propanediol, SD alcohol (5% w/w), glycine soja (soybean) sterols, steareth-21, stearic acid, triethanolamine, water, xanthan gum (309-018)

Principal Display Panel

ICY HOT®
ADVANCED
PAIN RELIEF CREAMNet WT 2 OZ (56 g)

Principal Display Panel 
ICY HOT®
ADVANCED
PAIN RELIEF CREAM
Net WT 2 OZ (56 g)
(click image for full-size original)
ICY HOT ADVANCED RELIEF camphor and menthol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0801
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 0.11 g in 1 g
MENTHOL (MENTHOL) MENTHOL 0.16 g in 1 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN
ALOE VERA LEAF
CETYL ALCOHOL
DIISOPROPYL ADIPATE
EDETATE DISODIUM
DIETHYLENE GLYCOL MONOETHYL ETHER
GLYCERIN
GLYCERYL MONOSTEARATE
MENTHYL LACTATE, (-)-
METHYLPARABEN
PEG-150 STEARATE
PENTYLENE GLYCOL
4-TERT-BUTYLCYCLOHEXANOL
PHENOXYETHANOL
POLYSORBATE 80
PROPANEDIOL
SOY STEROL
STEARETH-21
STEARIC ACID
TROLAMINE
WATER
XANTHAN GUM
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0801-0 1 TUBE in 1 CARTON contains a TUBE
1 56 g in 1 TUBE This package is contained within the CARTON (41167-0801-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 12/01/2012
Labeler — Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Operations
CHATTEM, INC. 830410721 analysis (41167-0801), label (41167-0801), manufacture (41167-0801), pack (41167-0801)

Revised: 10/2023 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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