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Kool Comfort Pain Relieving Roll-On

Dosage form: lotion
Ingredients: Menthol 3.5g in 100g
Labeler: Wonder Laboratories
NDC Code: 99528-3590

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.

Active Ingredient:                                                                     Purpose

Natural Menthol USP 3.5%....................................................Cooling Pain Relief

Uses:  Temporary relief of minor aches and pains of sore muscles and joints

associated with - arthritis - backache - strains - sprains

Warnings:  For external use only

Flammable:  Keep away from excessive heat or open flame

Ask a doctor before use if you have: Sensitive Skin

When Using This Product: Avoid contact with eyes or mucous membranes

- Do not apply to wounds or damaged skin - Do not use with other ointments, creams, sprays or liniments - Do not apply to irritated skin or if excessive irritation develops - Do not bandage - Wash hands after use with cool water - Do not use with heating pad or heating devices

Stop Use And Ask A Doctor If:  Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding:  Ask a health professional before use.

Keep out of reach of children:  If accidentally ingested, get medical help or contact a Poison Control Center right away

- Adults and children 2 years of age and older:  Roll on to the affected areas not more than 4 times daily; massage not necessary

- Children under 2 years of age:  Consult a physician

Other Information:  Store in a cool dry place with lid tightly closed

Inactive Ingredients: carbomer, FDC blue #1, FDC yellow #5, , glycerine, herbal extract (ILEX paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol USP, silicon dioxide, triethanolamine USP, water

KOOL COMFORT PAIN RELIEVING ROLL-ON 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:99528-3590
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
FD&C Blue No. 1 
FD&C Yellow No. 5 
CARBOMER HOMOPOLYMER TYPE C  
Silicon Dioxide 
Glycerin 
Propylene Glycol 
ILEX PARAGUARIENSIS LEAF  
Methylparaben 
Isopropyl Alcohol 
Camphor (Synthetic) 
Trolamine 
Product Characteristics
Colorgreen (mint green) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:99528-3590-3100 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2009
Labeler - Wonder Laboratories (078294223)
Registrant - U.S. Pharmaceuticals (009248480)
Establishment
NameAddressID/FEIOperations
U.S. Pharmaceuticals, Inc.009248480manufacture

Revised: 01/2009
 
Wonder Laboratories

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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