TEDS TOPICAL PAIN GEL ROLL ON- trolamine salicylate 10% gel 
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 gel

Active ingredient

Trolamine Salicylate - 10%

Purpose

Topical Pain Relief

Uses

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

Warnings

For external use only​

Allergy Alert

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

• use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or damaged skin

Stop use and ask a doctor if

• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present

• irritation develops

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

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

Directions

Use only as directed​

Adults and children over 2 years:

children under 2 years of age: Ask a doctor

Inactive ingredients:

Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Caprylyl Glycol, Carbomer, Cyclomethicone, Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water, Resveratrol, Salix Alba (Willow) Bark Extract, Triethanolamine.

Package Labeling

TedsRonOnrollonbox

TEDS TOPICAL PAIN GEL ROLL ON 
trolamine salicylate 10% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHANOLAMINE ISOSTEARATE (UNII: T8OTU5ECY5)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
WATER (UNII: 059QF0KO0R)  
RESVERATROL (UNII: Q369O8926L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-211-0385 g in 1 TUBE, WITH APPLICATOR; 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(58133-211)

Revised: 1/2021
Document Id: b8a17ba9-85cb-ad56-e053-2995a90a14d9
Set id: 84af0590-db35-2b23-e053-2a91aa0a89c0
Version: 2
Effective Time: 20210111
 
Cosmetic Specialty Labs, Inc.