ROTEX (ROTEX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]

ROTEX (ROTEX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]
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NDC 69379-038-01
Set ID 1c834710-1286-3266-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Home Aide Diagnostics, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • PURPOSE

    PURPOSE: Topical analgesic

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS
    Methyl Salicylate 35% ----------------------------- Counterirritant
    Capsaicin 0.038% ----------------------------------- Counterirritant
    Menthol 4% ---------------------------------------- Topical analgesic

  • INDICATIONS & USAGE

    INDICATIONS
    For the temporary relief of minor pain of muscles and joints associated with:

    • Arthritis
    • Simple Backache
    • Strains
    • Sprains
    • Bruises
  • WARNINGS

    WARNINGS
    FOR EXTERNAL USE ONLY.

    • Use only as directed
    • Do not bandage tightly
    • Do not use with a heating pad
    • Avoid contact with the eyes or mucous membranes
    • Do not apply to wounds, damaged, broken or irritated skin
    • A transient burning sensation may occur upon application but generally disappears in several days
    • If severe burning sensation occurs, discontinue use immediately and call a doctor
    • Do not expose the area treated with product to heat or direct sunlight
  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • Adults and children over 18 years:
    • Apply generously to affected area
    • Massage into painful area until thoroughly absorbed into skin
    • Repeat as necessary, not more than 3-4 times daily.
    • Wash hands with soap and water immediately after use.
    • Children 18 years or younger: ask a doctor

    Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF:

    • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • Redness is present or irritation develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • PREGNANCY OR BREAST FEEDING

    If pregnant of breast-feeding, ask a healthcare professional before use

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS
    aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose; odium; water

  • PRINCIPAL DISPLAY PANEL

    Rotex.jpg

  • INGREDIENTS AND APPEARANCE
    ROTEX 
    rotex pain relieving cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69379-038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE35 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.038 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69379-038-01120 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/10/2015
    Labeler - Home Aide Diagnostics, Inc. (783518983)
    Registrant - Zhejiang Bangli Medical Products Co. Ltd (421295875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Bangli Medical Products Co. Ltd421295875manufacture(69379-038)