Label: ACTIVE HYDROGEN PROFESSIONAL- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72316-001-01 - Packager: EXECUTIVE PRO SOLUTIONS DOO
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 11, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Warnings
- Purpose
- Uses
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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
- Stop use and ask doctor if
- Active ingridients
- Inactive Ingridients
- Product Label
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INGREDIENTS AND APPEARANCE
ACTIVE HYDROGEN PROFESSIONAL
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72316-001 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:72316-001-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 05/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/11/2018 Labeler - EXECUTIVE PRO SOLUTIONS DOO (506157273) Establishment Name Address ID/FEI Business Operations 8.0 IDEAL BALANCE D.O.O. BEOGRAD 506132408 manufacture(72316-001)