FASTRIN ACHES AND PAIN DEEP RELIEF- menthol, camphor cream 
Aidance Skincare & Topical Solutions, 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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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.)

Tube Label

FASTRIN ACHES AND PAIN DEEP RELIEF 
menthol, camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-605
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)11 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CLOVE OIL (UNII: 578389D6D0)  
CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)  
COTTONSEED OIL (UNII: H3E878020N)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SHEA BUTTER (UNII: K49155WL9Y)  
SILVER OXIDE (UNII: 897WUN6G6T)  
SORBIC ACID (UNII: X045WJ989B)  
TEA TREE OIL (UNII: VIF565UC2G)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-605-1010 g in 1 JAR; Type 0: Not a Combination Product06/01/2017
2NDC:24909-605-5050 g in 1 TUBE; Type 0: Not a Combination Product06/01/2017
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/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-605) , label(24909-605)

Revised: 6/2017
Document Id: 38b64015-bb2d-4854-aa9b-44df4cf97517
Set id: 1391377e-61b3-4d9b-a16b-c05700ef8af0
Version: 1
Effective Time: 20170601
 
Aidance Skincare & Topical Solutions, LLC