Myoflex®

Myoflex®
SPL v3
SPL
SPL Set ID 8eb6bb79-46c0-4cc2-a81a-fb3203b8c97f
Route
TOPICAL
Published
Effective Date 2013-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Aloe Vera Leaf Cetyl Alcohol Glycerin Dmdm Hydantoin Methylparaben Propylparaben Mineral Oil Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-24

Description

Drug Facts

Purpose

Pain relieving cream


Medication Information

Purpose

Pain relieving cream

Description

Drug Facts

Use
  • temporarily relieves minor aches and pains of muscles and joints due to arthritis, strains and sprains, and simple backache
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 53414-9

If you are pregnant or breast-feeding, ask a health care professional before use.

Warnings

For external use only

Directions
  • do not use more than directed
  • adults and children 2 years and older
    • apply to affected area not more than three to four times a day
    • may be covered with a sterile bandage
  • children under 2 years: ask a doctor
Do Not Use
  • in or near eyes
  • on wounds or damaged skin
Questions?

call 1-800-790-6417

Active Ingredient

Trolamine salicylate 10%

Other Information
  • store at controlled room temperature 20-25°C (68-77°F)
  • close cap tightly
Inactive Ingredients

aloe vera gel, cetyl alcohol, glycerin, DMDM hydantoin, methylparaben, propylparaben, mineral oil, stearic acid, triethanolamine, purified water

Stop Use and Ask A Doctor If
  • condition lasts or gets worse
  • symptoms last more than 7 days or clear up and occur again within a few days
Principal Display Panel 113 G Tube Box

NDC 55741-304-04

up to 8 - Hour Formula

MYOFLEX ®

PAIN RELIEVING CREAM

TROLAMINE SALICYLATE 10%

Targeted Relief From Minor Backache, Arthritis, Muscle & Joint Pain

Deep Penetrating      ✓ Odorless      ✓ Pharmacist Recommended

NET WT. 4 oz (113 g)


Structured Label Content

Use
  • temporarily relieves minor aches and pains of muscles and joints due to arthritis, strains and sprains, and simple backache
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 53414-9 (53414-9)

If you are pregnant or breast-feeding, ask a health care professional before use.

Purpose

Pain relieving cream

Warnings

For external use only

Directions
  • do not use more than directed
  • adults and children 2 years and older
    • apply to affected area not more than three to four times a day
    • may be covered with a sterile bandage
  • children under 2 years: ask a doctor
Do Not Use (Do not use)
  • in or near eyes
  • on wounds or damaged skin
Questions?

call 1-800-790-6417

Active Ingredient (Active ingredient)

Trolamine salicylate 10%

Other Information (Other information)
  • store at controlled room temperature 20-25°C (68-77°F)
  • close cap tightly
Inactive Ingredients (Inactive ingredients)

aloe vera gel, cetyl alcohol, glycerin, DMDM hydantoin, methylparaben, propylparaben, mineral oil, stearic acid, triethanolamine, purified water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition lasts or gets worse
  • symptoms last more than 7 days or clear up and occur again within a few days
Principal Display Panel 113 G Tube Box (PRINCIPAL DISPLAY PANEL - 113 g Tube Box)

NDC 55741-304-04

up to 8 - Hour Formula

MYOFLEX ®

PAIN RELIEVING CREAM

TROLAMINE SALICYLATE 10%

Targeted Relief From Minor Backache, Arthritis, Muscle & Joint Pain

Deep Penetrating      ✓ Odorless      ✓ Pharmacist Recommended

NET WT. 4 oz (113 g)


Advanced Ingredient Data


Raw Label Data

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