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Icy Cool Maximum Strength

Dosage form: gel
Ingredients: Menthol 55mg in 1mL
Labeler: C.D.M.A. Inc.
NDC code: 63868-633

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

DRUG FACTS

Active Ingredient

Natural Menthol 5.5%

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 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 in several 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

Flammable
  • keep away from fire of flame

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help of contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

  • apply generously to affected area
  • message into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children 12 years or younger, ask a doctor

Inactive ingredients –

AloeVera, Carbomer, FD&C Blue #1, Glycerine USP, Ilex Paraguariensis Extract, Isopropyl Alcohol USP, Camphor, Propylene Glycol USP, Methyl Paraben, Purified Water, Silicon Dioxide, Triethanolamine, Vitamin E

Principal Display Panel - 4 oz. Tube Label

QC Quality Choice

NDC 63868-0633-18

*Compare to BIOFREEZE®
Pain Relieving Gel

Maximum Strength

Icy CoolTM

Pain Relieving Gel

Natural Menthol 5.5% | Topical Analgesic

Relief From:
Aches and pains associated with strains, sprains, backaches, bruises and arthritis

With Aloe

1 Tube 4oz./118ml.

ICY COOL   MAXIMUM STRENGTH
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-633
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol55 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
CAMPHOR (SYNTHETIC) 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
FD&C BLUE NO. 1 
GLYCERIN 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
METHYLPARABEN 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:63868-633-18118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2013
Labeler - C.D.M.A. Inc. (011920774)
Registrant - NATURAL ESSENTIALS, INC. (947484713)
Establishment
NameAddressID/FEIOperations
NATURAL ESSENTIALS INC.947484713MANUFACTURE(63868-633)

Document Id: 0e6e835a-a87d-4a1b-b3c8-b3319b4f9473
Set id: ca17fe53-3dbe-4007-a33b-07738378a211
Version: 1
Effective Time: 20140814
 
C.D.M.A. Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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