Label: ZAXS ACHES AND PAIN- capsicum, methyl salicylate, menthol cream
- NDC Code(s): 54291-054-01
- Packager: Canadian Custom Packaging Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 11, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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WARNINGS
• For external use only.
•Allergy alert: If allergic to aspirin or salicylates, consult a physician before use.
•When using this product, use only as directed. Make sure you understand directions and warnings on label before use.
°Rare case of burns have been reported with products of this type.
°Do not apply with external heat (such as electric heating pad) or bandage tightly.
°Do not apply to wounds or damaged skin, or irritated skin.
°If you are allergic to any ingredient in this product, do not use. Avoid contact with eyes and mucous membranes.
•If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
•Stop use if: Redness is present, irritation develops, you experience pain, swelling or blistering where product is applied.
•Consult a physician if you are breastfeeding or pregnant before use.
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Aqua, Butyrospermum Parkii (Shea Butter) Extraxt, Caprylic/capric triglyceride, Caprylyl Glycol, Camphor, Carbomer copolymer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Eucalyptus Leaf Oil, Glycerin, Mentha piperita (Peppermint) oil, Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Sorbic acid, Xanthan Gum
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZAXS ACHES AND PAIN
capsicum, methyl salicylate, menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54291-054 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 1.3 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 105 mg in 1 g Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CAMPHOR (NATURAL) (UNII: N20HL7Q941) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) EUCALYPTUS OIL (UNII: 2R04ONI662) PEPPERMINT OIL (UNII: AV092KU4JH) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBIC ACID (UNII: X045WJ989B) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54291-054-01 120 g in 1 TUBE; Type 0: Not a Combination Product 11/22/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 11/22/2021 Labeler - Canadian Custom Packaging Company (207062514) Registrant - Canadian Custom Packaging Company (207062514) Establishment Name Address ID/FEI Business Operations Canadian Custom Packaging Company 207062514 manufacture(54291-054)