Label: ACTIVE HYDROGEN PROFESSIONAL CREAM- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72901-002-01 - Packager: 8.0 IDEAL BALANCE D.O.O. BEOGRAD
- 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 February 24, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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
- ACTIVE INGREDIENT
- Purpose
- Uses
- Directions
- KEEP OUT OF REACH OF CHILDREN
- Stop use and ask doctor if
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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
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INGREDIENTS AND APPEARANCE
ACTIVE HYDROGEN PROFESSIONAL CREAM
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72901-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72901-002-01 1 in 1 CARTON 03/28/2019 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/28/2019 Labeler - 8.0 IDEAL BALANCE D.O.O. BEOGRAD (506132408)