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Fastrin Aches and Pain Deep Relief

Medically reviewed on June 1, 2017

Dosage form: cream
Ingredients: MENTHOL 16g in 100g, CAMPHOR (SYNTHETIC) 11g in 100g
Labeler: Aidance Skincare & Topical Solutions, LLC
NDC Code: 24909-605

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 Ingredients

Menthol 16%, Camphor 11%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product - avoid contact with eyes or mucous membranes - do not bandage tightly or use with heating pad. Stop use and ask a doctor if - condition worsens or symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - excessive skin irritation develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years and older: Massage ointment into affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.

Inactive Ingredients

Beeswax, Clove Oil, Cottonseed Oil, Distilled Water, Emulsifying Wax, Eucalyptus Oil, Jojoba Seed Oil, Magnesium Oxide, Peppermint Oil, Shea Butter, Silver Oxide, Sorbic Acid, Tea Tree Oil, Zinc Oxide

PRINCIPAL DISPLAY PANEL - 50g Tube

Fastrin

Aches & Pain

Deep Relief Cream

Net WT 50g (1.76 oz.)

FASTRIN ACHES AND PAIN DEEP RELIEF 
menthol, camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-605
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL16 g  in 100 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)11 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL 
CLOVE OIL 
CORYMBIA CITRIODORA LEAF OIL 
COTTONSEED OIL 
JOJOBA OIL 
MAGNESIUM OXIDE 
PEPPERMINT OIL 
POLYSORBATE 60 
SHEA BUTTER 
SILVER OXIDE 
SORBIC ACID 
TEA TREE OIL 
WATER 
WHITE WAX 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:24909-605-1010 g in 1 JAR
2NDC:24909-605-5050 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2017
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIOperations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-605), label(24909-605)

 
Aidance Skincare & Topical Solutions, LLC

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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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