Drug Labeling and Warnings

Drug Details

k">

ICE MUSCLE RUB LEON M.C- menthol gel 
Southern Sales & Service, 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.

----------

Active Ingredients               Purpose

Menthol 2.0%                    Topical Anagesic

Purpose

Topical Analgesic

Uses

 temporary relief minor pains due to:

  • Arthritis
  • Muscle Strains
  • Minor Backaches
  • Sprains
  • Cramps
  • Bruces

Warnings

For external use only

When using this product

  • Keep away from eyes and Mouthdo not bandage tightly
  • Do not apply to wounds or broken skin
  • Do not bandage or use with heating pad.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

adults and children over 12 years:

  • Aapply to affected area and massage until Gel is absorved
  • Repeat as necesary but no more than 4 times daily
  • Children 12 years or younger:Ask your doctor

Inactive ingredients carbomer, propylene glycol, methylparaben, isopropyl alcohol, triethanolamine, FD&C Blue #1, water

Distributed by

Leon Medical Centers, Ic.

Miami, FL 33165

Question or Comments?

Call 1 800.213.9370

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Irritation develops

Leon Medical Muscle Rub Gel

Label Image
ICE MUSCLE RUB LEON M.C 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69822-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69822-103-08 227 g in 1 TUBE; Type 0: Not a Combination Product01/04/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2013
Labeler - Southern Sales & Service, Inc. (013114906)
Establishment
NameAddressID/FEIBusiness Operations
Southern Sales & Service, Inc.013114906LABEL(69822-103)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-103)

Revised: 1/2017
 
Southern Sales & Service, Inc.


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.