TEDS TOPICAL PAIN CREAM- methyl salicylate 10% cream 
Cosmetic Specialty Labs, Inc.

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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ted's Brain Science Products pain cream

Active ingredient

Methyl Salicylate - 10%

Purpose

Topical Pain Relief

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruises and • sprains

Warnings

For external use only​

Allergy Alert

If you had prior allergic reaction to aspirin or salicylate, please consult a physician before use.

Do not use

  • on wounds or damaged skin
  • with a heating pad

Ask a physician before use if

  • you have redness over the affected area

When using this product

​ • use only as directed • avoid contact with eyes and muscous membranes • do not bandage tightly

Stop use and ask a physician if

• condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation occurs • pregnant or breast-feeding

Keep out of reach of the children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

Use only as directed​

adults and children 2 years of age and older:

children under 2 years of age: consult a physician

Other Information

Store at 20ºC to 25ºC (68ºF - 77ºF)

Inactive ingredients:

Aqua (deionized water), Arnica Montana (arnica) Extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, PEG-100 stearate, phenoxyethanol, polysorbate 20, resveratrol, sodium laurylglucosides, hydroxypropylsulfonate, sorbitan olivate, stearic acid

Package Labeling

Tedspaincream

TEDS TOPICAL PAIN CREAM 
methyl salicylate 10% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
RESVERATROL (UNII: Q369O8926L)  
SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)  
SODIUM HYDROXYPROPYLSULFONATE LAURYLGLUCOSIDE-7 CROSSPOLYMER (UNII: K9R4VJQ1IB)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-210-0385 g in 1 TUBE; Type 0: Not a Combination Product03/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/21/2019
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Registrant - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-210)

Revised: 1/2021
Document Id: b8a17775-e842-12ce-e053-2a95a90a2887
Set id: 849d6e28-a6c1-7f49-e053-2a91aa0a497d
Version: 2
Effective Time: 20210111
 
Cosmetic Specialty Labs, Inc.