KERASAL PF-10  - menthol lotion 
Alterna, LLC

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Kerasal PF-10 Label

Warnings: For external use only: Flammable: Keep away from excessive heat or open flame. Ask a doctor before use if you have sensitive skin

Uses: Provides temporary pain relief of: Minor arthritis pain. Muscle sprains. Bruises. Simple backaches. Muscle strains. Cramps. Tendonitis. Bursitis.

When Using

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.

Pregnancy or Breast Feeding Section

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

Keep out of reach of Children

Keep out of reach of children. If accidentally swallowed, contact a doctor or poison control center immediately.

Stop Use

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.

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.

Questions Section

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.

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 mucas 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.Active Ingredients Purpose Natural Menthol, USP (8.5%). Topical Analgesic. 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.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 

KERASAL PF-10  natural menthol   lotion

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 16864-012 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (Menthol) Menthol 8.5 mg  in 88 mL

Inactive Ingredients Ingredient Name Strength 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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 16864-012-01 88 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/24/2010

Labeler - Alterna, LLC (192527062)

Establishment
Name	Address	ID/FEI	Operations
Smart Science		035907919	manufacture

Revised: 06/2010Alterna, LLC