MYOFLEX- trolamine salicylate cream

Myoflex by

Drug Labeling and Warnings

Myoflex by is a Otc medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Trolamine salicylate 10%

Purpose

Pain relieving cream

Use

• temporarily relieves minor aches and pains of muscles and joints due to arthritis, strains and sprains, and simple backache

Warnings

For external use only

Do not use

• in or near eyes
• on wounds or damaged skin

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

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

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

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

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

Questions?

call 1-800-790-6417

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)

INGREDIENTS AND APPEARANCE

MYOFLEX 
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55741-304
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
aloe vera leaf (UNII: ZY81Z83H0X)
cetyl alcohol (UNII: 936JST6JCN)
glycerin (UNII: PDC6A3C0OX)
DMDM hydantoin (UNII: BYR0546TOW)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
mineral oil (UNII: T5L8T28FGP)
stearic acid (UNII: 4ELV7Z65AP)
trolamine (UNII: 9O3K93S3TK)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55741-304-04	1 in 1 BOX	05/24/2016
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/24/2016

Labeler - Dr. Reddy's Laboratories Inc. (802315887)