ACTIVE HYDROGEN PROFESSIONAL CREAM- menthol cream 
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.

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Active HYDROGEN PROFESSIONAL cream

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

Directions

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 one again.

• repeat the process minimum 3 times per day 

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

Use within 90 days after opening the product.

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

Inactive Ingredients

Ascorbic Acid, Aqua, Boric Acid, Butylated Hydroxytoluene, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Ethylhexanoate, Disodium Edta, Glycerol, Glyceryl Stearate (and) Ceteareth-20 (and) Ceteareth-12 (and) Cetearyl Alcohol (and) Cetyl Palmitate, Magnesium Oxide, Paraffinum Liquidum, Perfume, Phenoxyethanol (and) Ethylhexylglycerin, Propylene Glycol, Tocopheryl Acetate.

Product label

image descriptionimage descriptionimage description

ACTIVE HYDROGEN PROFESSIONAL CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72901-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BORIC ACID (UNII: R57ZHV85D4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72901-002-011 in 1 CARTON03/28/2019
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/28/2019
Labeler - 8.0 IDEAL BALANCE D.O.O. BEOGRAD (506132408)

Revised: 2/2022
Document Id: d8cb23e6-09b9-f412-e053-2995a90a782b
Set id: 4c48acd0-4b08-4560-8fbc-3a05a7d5a57d
Version: 3
Effective Time: 20220224
 
8.0 IDEAL BALANCE D.O.O. BEOGRAD