MYOFLEX- trolamine salicylate cream 
Dr. Reddy's Laboratories 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.

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Myoflex®

Drug Facts

Active ingredient

Trolamine salicylate 10%

Purpose

Pain relieving cream

Use

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

Other information

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)

Principal Display Panel - 113 g Tube Box
MYOFLEX 
trolamine salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Trolamine salicylate (UNII: H8O4040BHD) (Salicylic Acid - UNII:O414PZ4LPZ) Trolamine salicylate10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55741-304-041 in 1 BOX05/24/2016
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/24/2016
Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Revised: 6/2016
Document Id: fb1dd946-d939-64b0-3f9f-b6e249ce0888
Set id: 8eb6bb79-46c0-4cc2-a81a-fb3203b8c97f
Version: 3
Effective Time: 20160615
 
Dr. Reddy's Laboratories Inc.