The following Structured Product Label (SPL) was submitted to the FDA by 8.0 Ideal Balance D.o.o. Beograd for the product Active Hydrogen Professional Cream (NDC 72901-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, purpose, uses, directions, stop use and ask doctor if, active ingredient, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
• 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
Topical analgesic
Reduces and stops the inflammatory process, eliminates pain, reduces swelling, speeds up
recovery process after injuries, neutralizes excretion of lactic acid in the muscles
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
• condition worsens
• redness is present
• irritation develops
• symptoms persist for more then 7 days or clear up and occur again within a few days
Menthol 7.0 %
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.
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