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

teds topical pain gel roll on by

Drug Labeling and Warnings

teds topical pain gel roll on by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• Apply generously to affected area
• massage into painful area until thoroughly absorbed
• into skin
• repeat as necessary, but no more than 3 to 4 times daily

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

INGREDIENTS AND APPEARANCE

TEDS TOPICAL PAIN GEL ROLL ON 
trolamine salicylate 10% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
WATER (UNII: 059QF0KO0R)
RESVERATROL (UNII: Q369O8926L)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-211-03	85 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	03/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/21/2019

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Registrant - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-211)