KERASAL PF-10  - menthol lotion 
Alterna, LLC

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

Natural Menthol, USP (8.5%)

Purpose

Topical Analgesic

Uses:

Provides temporary pain relief of:

  • Minor arthritis pain
  • Muscle sprains
  • Bruises
  • Simple backaches
  • Muscle strains
  • Cramps

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:

  • Do not use on wounds or irritated skin
  • Do not bandage tightly or use with a heating pad
  • Wash hands after use with cool water
  • Avoid contact with eyes or mucous membranes

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

If accidentally swallowed, contact a doctor or poison control center immediately.

Stop use and ask a doctor

if condition worsens or if pain persists for more than 7 days, or clears up, then reoccurs within a few days, or if excessive skin irritation occurs.

Directions

  • Use only as directed
  • Do not use on children under 12 years of age
  • Roll onto affected area no more than four times daily.

Inactive Ingredient Section

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Arnica Montana Extract, Boswellia Serrata Extract, Camphor, Carbomer, Chondroitin Sulfate, Glucosamine Sulfate, Glycerin, Ilex Paraguarensis Extract, Isopropyl Alcohol, Methyl Paraben, Methylsulfonylmethane, Peppermint Oil, Polysorbate 20, Propylene Glycol, Triethanolamine, Purified Water.

Other Information:

Questions or comments? Visit our website at www.kerasal.com or call (877) 674-3475. Store in a cool dry place with the cap tightly closed. Note: Because this product contains natural ingredients, color may vary.

Principal Display Label

Kerasal®
Topical Pain Formula

PF-10

With Natural Menthol
in a soothing base of
Arnica • Boswellia • Illex • MSM
Camphor • Chondroitin Sulfate • Aloe
Glucosamine • Peppermint Oil

Penetrating relief from
ARTHRITIS, MUSCLE ACHE, JOINT AND FOOT PAIN

Guaranteed Pain Relief

3FL OZ (88ML)

®TM ©2010, Dist. by Alterna LLC, 7 East Frederick Place, Suite 100 Cedar Knolls, NJ 07927
FDA Drug Registration No. NDC 16864-012. All Rights Reserved. Made in USA   ALT-PF10.2B

Kerasal PF-10 Label
KERASAL PF-10  
natural menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol8.5 mg  in 88 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARNICA MONTANA 
CARBOMER 934 
GLUCOSAMINE SULFATE 
GLYCERIN 
ISOPROPYL ALCOHOL 
METHYLPARABEN 
PEPPERMINT OIL 
POLYSORBATE 20 
PROPYLENE GLYCOL 
TROLAMINE 
WATER 
INDIAN FRANKINCENSE 
CHONDROITIN SULFATE (BOVINE) 
ILEX PARAGUARIENSIS LEAF 
Dimethyl Sulfone 
Camphor (synthetic) 
Packaging
#Item CodePackage Description
1NDC:16864-012-0188 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/24/2010
Labeler - Alterna, LLC (192527062)
Establishment
NameAddressID/FEIBusiness Operations
Smart Science035907919MANUFACTURE(16864-012)

Revised: 10/2012
 
Alterna, LLC