TEDS TOPICAL PAIN CREAM- methyl salicylate 10% cream

teds topical pain cream by

Drug Labeling and Warnings

teds topical pain cream 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

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:

• apply to affected area not more than 3 or 4 times daily

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

INGREDIENTS AND APPEARANCE

TEDS TOPICAL PAIN CREAM 
methyl salicylate 10% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-210-03	85 g in 1 TUBE; 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(58133-210)