Teds Topical Pain Gel Roll On: Package Insert and Label Information

TEDS TOPICAL PAIN GEL ROLL ON- trolamine salicylate 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.

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

TedsRonOn
(click image for full-size original)
rollonbox
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROLAMINE SALICYLATE (SALICYLIC ACID) TROLAMINE SALICYLATE 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ARNICA MONTANA FLOWER
WATER
RESVERATROL
BOSWELLIA SERRATA RESIN OIL
GLYCERIN
PHENOXYETHANOL
ALOE VERA LEAF
CARBOMER 940
CYCLOMETHICONE
TRIETHANOLAMINE ISOSTEARATE
CAPRYLYL GLYCOL
PROPYLENE GLYCOL DIETHYLHEXANOATE
SALIX ALBA BARK
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58133-211-03 85 g in 1 TUBE, WITH APPLICATOR None
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 Operations
Cosmetic Specialty Labs, Inc. 032973000 manufacture (58133-211)

Revised: 03/2019 Cosmetic Specialty Labs, Inc.

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