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Icy Cool Maximum Strength by C.D.M.A. Inc.

Dosage form: gel
Ingredients: Menthol 55mg in 1mL
Labeler: C.D.M.A. Inc.
NDC Code: 63868-632

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.

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 –

Aloe Barbadensis Leaf Extract, Carbomer, FD&C Blue #1, Glycerine USP, Ilex Paraguariensis Extract, Isopropyl Alcohol USP, Camphor, Propylene Glycol USP, Methyl Paraben, Purified Water, Silicon Dioxide, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine

Principal Display Panel - 3 oz. Roll on Label

QC Quality Choice

NDC 63868-632-82

*Compare to BIOFREEZE®
Pain Relieving Gel

Maximum Strength

Icy CoolTM with aloe

Pain Relieving Roll-On

Natural Menthol 5.5% | Topical Analgesic

Relief From Aches and Pains Associated with Strains, Sprains, Backaches, Bruises and Arthritis

1 Roll-on 3oz./89mL.

ICY COOL   MAXIMUM STRENGTH
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-632
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:63868-632-8289 mL in 1 BOTTLE, WITH APPLICATOR
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(63868-632)

Revised: 08/2014
 
C.D.M.A. Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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