ICE MUSCLE RUB LEON M.C- menthol gel

ICE MUSCLE RUB Leon M.C by

Drug Labeling and Warnings

ICE MUSCLE RUB Leon M.C by is a Otc medication manufactured, distributed, or labeled by Southern Sales & Service, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients               Purpose

Menthol 2.0%                    Topical Anagesic

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

 temporary relief minor pains due to:

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

INGREDIENTS AND APPEARANCE

ICE MUSCLE RUB LEON M.C 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69822-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69822-103-08	227 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2013

Labeler - Southern Sales & Service, Inc. (013114906)

Establishment
Name	Address	ID/FEI	Business Operations
Southern Sales & Service, Inc.		013114906	LABEL(69822-103)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(69822-103)