Label: ACTIVICE- menthol gel
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NDC Code(s):
53329-984-04,
53329-984-06,
53329-984-16,
53329-984-23, view more53329-984-25, 53329-984-30
- Packager: Medline Industries, LP
- 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 August 23, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Avoid contact with eyes.
Flammable: keep away from fire or flame.
When using this product
- use only as directed
- do not bandage tightly or use with heating pad
- do not apply to wounds or damaged skin
- Directions
- Other information
- Inactive ingredients
- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
ACTIVICE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-984 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength PENTYLENE GLYCOL (UNII: 50C1307PZG) WATER (UNII: 059QF0KO0R) PEG-8 DIMETHICONE (UNII: GIA7T764OD) TROLAMINE (UNII: 9O3K93S3TK) PEPPERMINT OIL (UNII: AV092KU4JH) ALCOHOL (UNII: 3K9958V90M) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) EUCALYPTUS OIL (UNII: 2R04ONI662) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-984-04 118 mL in 1 TUBE; Type 0: Not a Combination Product 03/04/2019 2 NDC:53329-984-23 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/04/2019 3 NDC:53329-984-25 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/04/2019 4 NDC:53329-984-30 100 in 1 BOX 03/04/2019 4 5.6 mL in 1 PACKET; Type 0: Not a Combination Product 5 NDC:53329-984-06 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/04/2019 6 NDC:53329-984-16 5.6 mL in 1 PACKET; Type 0: Not a Combination Product 03/04/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/04/2019 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)