Label: RECOVERY ROLL-ON- menthol, camphor gel
- NDC Code(s): 75249-008-01
- Packager: SOLITEINT KOZMETIKUM GYARTO ES FORGALMAZO TERMELO ES KERESKEDELMI KORLATOLT FELELOSSEGU TARSASAG
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated February 13, 2023
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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 tightly or use with a heating pad, other ointments, creams, sprays, or liniments.
- Directions
- Other Information
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Inactive Ingredients
Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Dimethyl Sulfone, Magnesium Chloride, Cetearyl Alcohol, Glyceryl Stearate, Polyglyceryl-6 Palmitate/Succinate, Glycerin, Hydroxyacetophenone, Tocopheryl Acetate, Xanthan Gum, Caprylyl Glycol, 1,2-Hexanediol, Acacia Senegal Gum, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Magnesium Sulfate, Potassium Chloride, Sodium Chloride, Calcium Chloride
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INGREDIENTS AND APPEARANCE
RECOVERY ROLL-ON
menthol, camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75249-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 5 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ACACIA (UNII: 5C5403N26O) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SODIUM CHLORIDE (UNII: 451W47IQ8X) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) GLYCERIN (UNII: PDC6A3C0OX) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75249-008-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/17/2022 Labeler - SOLITEINT KOZMETIKUM GYARTO ES FORGALMAZO TERMELO ES KERESKEDELMI KORLATOLT FELELOSSEGU TARSASAG (401476254) Establishment Name Address ID/FEI Business Operations SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag 401476254 manufacture(75249-008)