teeter renew muscles pain relieving cream

teeter renew muscles pain relieving cream
SPL v4
SPL
SPL Set ID b90dc5b9-c31d-4770-a291-98d036ae8723
Route
topical
Published
Effective Date 2016-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (100 mg) menthol (70 mg)
Inactive Ingredients
water arnica montana indian frankincense c13-14 isoparaffin cetyl alcohol orange oil dimethyl sulfone emu oil diethylene glycol monoethyl ether gluconolactone glucosamine sulfate glycerin glyceryl monostearate isopropyl myristate laureth-7 peg-100 stearate polysorbate 20 sodium benzoate stearic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-03-12

Purpose

Topical Analgesic

Description

Methyl Salicylate 10.0% Menthol 7.0%


Medication Information

Warnings

For external use only.

Uses

Temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache • arthritis • strains • bruises • sprains

Purpose

Topical Analgesic

Directions

Use only as directed

• Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: consult a physician

Other Information

• Store at 20° to 25°C (68°-77°F)

Inactive Ingredients

Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, C13-14 isoparaffin, cetyl alcohol, citrus aurantium dulcis (orange) peel oil, chondroitin sulfate, dimethyl sulfone (MSM), emu oil, ethoxydiglycol, gluconolactone, glucosamine sulfate, glycerin, glyceryl stearate, isopropyl myristate, laureth-7, PEG-100 stearate, polyacrylamide, polysorbate-20, sodium benzoate, stearic acid.

Description

Methyl Salicylate 10.0% Menthol 7.0%

Do Not Use

• on wounds or damaged skin • with a heating pad

Allergy Alert:

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

Package Labeling

Active Ingredients

Methyl Salicylate 10.0%

Menthol 7.0%

When Using This Product

• avoid contact with eyes and mucus membranes • do not bandage tightly

Keep Out of Reach of Children.

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

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 breastfeeding

Ask A Physician Before Use If You Have

redness over the affected area.


Structured Label Content

Warnings

For external use only.

Uses

Temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache • arthritis • strains • bruises • sprains

Purpose

Topical Analgesic

Directions

Use only as directed

• Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: consult a physician

Other Information (Other information)

• Store at 20° to 25°C (68°-77°F)

Inactive Ingredients

Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, C13-14 isoparaffin, cetyl alcohol, citrus aurantium dulcis (orange) peel oil, chondroitin sulfate, dimethyl sulfone (MSM), emu oil, ethoxydiglycol, gluconolactone, glucosamine sulfate, glycerin, glyceryl stearate, isopropyl myristate, laureth-7, PEG-100 stearate, polyacrylamide, polysorbate-20, sodium benzoate, stearic acid.

Do Not Use (Do not use)

• on wounds or damaged skin • with a heating pad

Allergy Alert:

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

Package Labeling

Active Ingredients

Methyl Salicylate 10.0%

Menthol 7.0%

When Using This Product (When using this product)

• avoid contact with eyes and mucus membranes • do not bandage tightly

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask A Physician If (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 breastfeeding

Ask A Physician Before Use If You Have (Ask a physician before use if you have)

redness over the affected area.


Advanced Ingredient Data


Raw Label Data

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