REED THERAPEUTICS PAIN RELIEVING THERAPY- methyl salicylate, menthol usp, camphor gel 
Reed Therapeutics

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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Reed Therapeutics Pain Relieving Therapy

Drug Facts

Active Ingredient,          Purpose

Methyl Salicylate 12.5%, Topical Analgesic/Anti-Inflammatory

Menthol USP 4%,             Topical Analgesic

Camphor 0.2%,               Topical Analgesic, Anti-Inflammatory

Uses

Temporary relief of minor aches and pain of sore muscles and joints associated with: arthritis, backache, bursitis, muscle cramps, muscle strain and sprains, plantar fasciitis, tendonitis

Warnings

For external use only. Keep away from excessive heat or open flame.

If pregnant or breast-feeding: Ask healthcare professional before use.

Keep out of reach of children

If accidently ingested, seek medical help or contact Poison Control Center immediately.

When using this product

When using this product:

Avoid contact with eyes or mucous membranes

Do not apply to wounds or damaged skin

Do not bandage

Do not use with heating pad or device

Do not use with other ointments, cream, sprays, or liniments

Stop use and ask a doctor if

Stop use and ask a doctor if

Condition worsens or if symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

Directions

Adults and children 12 year and older: Gently massage and apply to affected area 3-4 times daily. Massage not necesssary but may enhance relief.

Children under 12 years of age: consult a physician.

Other Information

Store at controlled room temperture 68' to 77' F. Close cap after use.

Inactive Ingredients

Carbomer 940, DMDM Hydantoin, FD&C Blue #1, Paragurariensis Extract, Methylparaben, Propylparaben, Tea Tree oil, Thyme oil, Triethanolamine, Water(D.I), FD&C Yellow #5

Label of Rollon

REED THERAPEUTICS PAIN RELIEVING THERAPY 
methyl salicylate, menthol usp, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76437-609
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE12.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ILEX PARAGUARIENSIS WHOLE (UNII: QJB02841ZY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TEA TREE OIL (UNII: VIF565UC2G)  
THYME OIL (UNII: 2UK410MY6B)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76437-609-0387 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/29/2013
Labeler - Reed Therapeutics (032505137)
Registrant - Geritrex (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex112796248manufacture(76437-609)

Revised: 3/2013
Document Id: f1f6551d-a099-427f-a223-79a6151523ee
Set id: 5ee37805-f1c6-467a-bdf2-f67368347e11
Version: 1
Effective Time: 20130329
 
Reed Therapeutics