Label: RELIEVE YOUR PAIN- menthol cream
- NDC Code(s): 75249-005-01
- Packager: SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag
- 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 11, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
Use only as directed. For external use only.
When using this product:
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged skin
- do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments.
- Directions
- Other Information
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Inactive Ingredients
Aqua, Magnesium Chloride, Dimethyl Sulfone (Methylsulfonylmethane), Glyceryl Stearate SE, Cetearyl Alcohol, Sweet Almond Oil (Prunus Amygdalus Dulcis), Shea Butter (Butyrospermum Parkii), Ceteareth-20, Glycerin, Pentylene Glycol, Undecane, Tocopheryl Acetate, Cetyl Palmitate, Arnica Montana Flower Extract, Tocopherol, Xanthan Gum, Tridecane, Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Calcium Chloride, Ascorbyl Palmitate, Hydroxyacetophenone
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INGREDIENTS AND APPEARANCE
RELIEVE YOUR PAIN
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75249-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 g Inactive Ingredients Ingredient Name Strength TRIDECANE (UNII: A3LZF0L939) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETYL PALMITATE (UNII: 5ZA2S6B08X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM CHLORIDE (UNII: 660YQ98I10) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SHEA BUTTER (UNII: K49155WL9Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) UNDECANE (UNII: JV0QT00NUE) ASCORBYL PALMITATE (UNII: QN83US2B0N) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) WATER (UNII: 059QF0KO0R) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) ALMOND OIL (UNII: 66YXD4DKO9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75249-005-01 96 g in 1 TUBE; Type 0: Not a Combination Product 04/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/29/2021 Labeler - SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag (401476254) Establishment Name Address ID/FEI Business Operations SOLITEINT Ko zmetikum gyarto es fo rgalmazo termelo es kereskedelmi Ko rlato lt Felelo ssegu Tarsasag 401476254 manufacture(75249-005)