Kool Comfort Pain Relieving Roll-On by Wonder Laboratories / U.S. Pharmaceuticals / U.S. Pharmaceuticals, Inc.

Kool Comfort Pain Relieving Roll-On by

Drug Labeling and Warnings

Kool Comfort Pain Relieving Roll-On by is a Homeopathic medication manufactured, distributed, or labeled by Wonder Laboratories, U.S. Pharmaceuticals, U.S. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KOOL COMFORT PAIN RELIEVING ROLL-ON- menthol lotion 
Wonder Laboratories

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.

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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

Product Label
KOOL COMFORT PAIN RELIEVING ROLL-ON 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 99528-3590
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
TROLAMINE (UNII: 9O3K93S3TK)  
Product Characteristics
Colorgreen (mint green) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 99528-3590-3100 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/200907/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/200907/15/2019
Labeler - Wonder Laboratories (078294223)
Registrant - U.S. Pharmaceuticals (009248480)
Establishment
NameAddressID/FEIBusiness Operations
U.S. Pharmaceuticals, Inc.009248480manufacture(99528-3590)

Revised: 11/2019
 

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