Label: AMBIX FIRST AID- dyclonine hydrochloride and phenol cream

  • 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 November 4, 2019

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  • Active Ingredients

    Phenol 0.5%

    Dyclonine Hydrochloride 0.5%

  • Purpose

    First Aid Antiseptic

    Topical Anesthetic

  • Uses

    • first aid to help protect against infection and for the temporary relief of pain and itching associated with minor burns, minor cuts, scrapes, insect bites, or minor skin irritations.
  • Warnings

    ■ For external use only ■ Do not bandage ■ Do not use in the eyes or apply over large areas of the body ■ Do not use longer than 1 week unless directed by a doctor

  • DO NOT USE

    Do not use in eyes, do not apply over large areas of the body. In case of deep puncture wounds or serious burns, consult a doctor.

  • Ask a doctor before use if you have

    a deep or puncture wound, an animal bite, serious burn, or before using on a child aged 2 or under.

  • Stop use and ask a doctor if

    redness, irritation, swelling, or pain persists or increases.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ Clean the affected area ■ Apply a small amount of this product on the area 1 to 3 times daily

  • Other Information

    • Store at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF).
    • You may report serious side effects to the phone number provided under “Questions?” below
  • Inactive Ingredients

    Allantoin, Benzyl Alcohol, Disodium EDTA, Glyceryl Stearate, Mineral Oil, Methyl Paraben, Petrolatum, Propyl Paraben, Sodium Lauryl Sulfate, Stearic Acid, Stearyl Alcohol, Triethanolamine, Water

  • PRINCIPAL DISPLAY PANEL


    Ambix

    FIRST AID

    Antiseptic & Pain Relieving Cream

    Net Wt. 7/8 oz. (25 grams)

    Dist. by Ambix Laboratories, Totowa, NJ 07512 ■ Made in USA ■ © 2013

    Ambix

    FIRST AID

    Antiseptic & Pain Relieving Cream

    Net Wt. 1-1/2 oz. (42.5 grams)

    Dist. by Ambix Laboratories, Totowa, NJ 07512 ■ Made in USA ■ © 2013

    First Aid Cream, 25g

    First Aid Cream, 42.5g

  • INGREDIENTS AND APPEARANCE
    AMBIX FIRST AID 
    dyclonine hydrochloride and phenol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10038-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE0.005 g  in 1 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.005 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10038-250-251 in 1 BOX08/22/2013
    125 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10038-250-421 in 1 BOX08/22/2013
    242.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/22/2013
    Labeler - Organics Corporation of America dba Ambix Laboratories (061061164)
    Registrant - Organics Corporation of America dba Ambix Laboratories (061061164)
    Establishment
    NameAddressID/FEIBusiness Operations
    Suite K Value Added Services LLC036822144manufacture(10038-250)
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