ACTIVE HYDROGEN PROFESSIONAL GEL- menthol gel 
8.0 IDEAL BALANCE D.O.O. BEOGRAD

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 HYDROGEN Professional gel

Warnings

• use only as directed

• do not bandage or use with heating pad or medicated patch

• avoid contact with eyes and mucous membranes

• do not apply to open wounds or damaged, broken or irritated skin

• a slight burning may occur upon application with disappearing effect in short period of time

Purpose 

Topical analgesic

Uses

Reduces and stops the inflammatory process, eliminates pain, reduces swelling, speeds up
recovery process after injuries, neutralizes excretion of lactic acid in the muscles

Dosage and Administration

adults and children over 12 years:
• apply a thin layer to the target - the sore spot
• massage into painful area until thoroughly absorbed into skin

• repeat the process several (4 to 5) times • wipe over with wet hand to remove any sense of tension

• repeat the process minimum 3 times per days Children 12 years or younger: ask a doctor

If preganant or breast-feeding, ask a health professional before use.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Stop use and ask doctor if

• condition worsens

• redness is present

• irritation develops
• symptoms persist for more then 7 days or clear up and occur again within a few days

Active ingredient

Menthol 1.2 % 

Inactive Ingredients

Aqua, Ascorbic Acid, Boric Acid, Carboxy Methyl Cellulose, Magnesium Oxide, Potassium Sorbate, Glycerol.

Product Label

product label

ACTIVE HYDROGEN PROFESSIONAL GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72901-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AQUA REGIA (UNII: X3TT5X989E)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BORIC ACID (UNII: R57ZHV85D4)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
GLYCEROL (1-(12-HYDROXYSTEARATE)) (UNII: X84XWP4TOC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72901-001-01100 mL in 1 TUBE; Type 0: Not a Combination Product03/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/13/2019
Labeler - 8.0 IDEAL BALANCE D.O.O. BEOGRAD (506132408)
Establishment
NameAddressID/FEIBusiness Operations
8.0 IDEAL BALANCE D.O.O. BEOGRAD506132408manufacture(72901-001)

Revised: 3/2019
Document Id: 7efedc35-88e1-4374-8cb1-188b83626f97
Set id: 3c5f7e57-b6c7-4372-ab1e-4aa2cb8bf2f1
Version: 1
Effective Time: 20190313
 
8.0 IDEAL BALANCE D.O.O. BEOGRAD