Label: SUBIR EYELASH- setting cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 31, 2021

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  • Active Ingredient(s)

    Sodium Bromate 12%

  • Purpose

    For permanent wave

  • Use

    Subir Eyelash Setting Cream for eyelash permanent wave

  • Warnings

    • Be careful not to get in your eyes.
    • If it gets into your eyes, immediately wash it off with clean water several times.
    • Wear appropriate gloves during the procedure.
    • Do not eat.
    • Keep out of reach of children.
    • Store in a cool place away from direct sunlight.
    • Recommended for single use only.
    • For professional use only.
    • Follow the recommendations.
    • After use, if skin irritation such as rash or itching persists, stop use and consult a doctor or pharmacist

  • KEEP OUT OF REACH OF CHILDREN

     Keep out of reach of children.

  • Directions

    • After desired time has passed, remove perm cream (step1). Use a newly moistened cotton pad to remove all traces of perm cream (step1)
    • Follow the same application technique to apply setting cream(step2), as you did to (step1).
    • After removing the perm cream, apply the setting cream and after 10 ~ 12 minutes, remove the set cream using a newly moistened cotton pad (depending on the texture of the lashes).

  • Other information

    ・ Store in room temperature 0~30℃
    ・ Avoid direct sunlight.

  • Inactive ingredients

    Water, PolyPropyleneGlycol-7, Cetearyl Alcohol, Mineral Oil, Cetyl Alcohol, Stearyl Alcohol

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    SUBIR EYELASH 
    setting cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81716-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STRONTIUM BROMATE (UNII: 1T54WJB20V) (STRONTIUM BROMATE - UNII:1T54WJB20V) STRONTIUM BROMATE0.084 g  in 0.7 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81716-003-010.7 g in 1 POUCH; Type 0: Not a Combination Product03/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/31/2021
    Labeler - Dream Polymer (695501990)
    Registrant - Dream Polymer (695501990)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dream Polymer695501990manufacture(81716-003)