ACTIVE HYDROGEN PROFESSIONAL GEL- menthol gel

Active HYDROGEN Professional gel by

Drug Labeling and Warnings

Active HYDROGEN Professional gel by is a Otc medication manufactured, distributed, or labeled by 8.0 IDEAL BALANCE D.O.O. BEOGRAD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

• For external use only
• When using this product

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

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

ACTIVE HYDROGEN PROFESSIONAL GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72901-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72901-001-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/13/2019

Labeler - 8.0 IDEAL BALANCE D.O.O. BEOGRAD (506132408)

Establishment
Name	Address	ID/FEI	Business Operations
8.0 IDEAL BALANCE D.O.O. BEOGRAD		506132408	manufacture(72901-001)