Label: ACNE PATCHS- carboxymethylcellulose patch

  • 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 January 6, 2021

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  • SPL UNCLASSIFIED SECTION

    ACNE PATCH

  • Active Ingredient(s)

    CARBOXYMETHYLCELLULOSE 1.5mg/patch. Purpose: Acne Treatment

  • Purpose

    ACNE PATCH, Acne Treatment

  • Use

    For the treatment pf acne.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
  • WHEN USING

    When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.

    If irritation occurs, only one medication should be used. Do not use if you are allergic to the dressing or any of the components.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Cleanse thoroughly before applying medication. Apply sticker on affected area. Leave on for 6 hours or overnight and remove. If dryness or peeling occur reduce application to once a day or every other day. New users should apply product sparingly to 1 or 2 small affected areas for the first 3 days of usage to test for sensitivity if no discomfort occurs, use a directed above.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Propylene glycol

  • Package Label - Principal Display Panel

    12

  • INGREDIENTS AND APPEARANCE
    ACNE PATCHS 
    carboxymethylcellulose patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81400-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81400-101-0115 in 1 BOX; Type 0: Not a Combination Product01/07/2021
    2NDC:81400-101-0252 in 1 BOX; Type 0: Not a Combination Product01/07/2021
    3NDC:81400-101-0362 in 1 BOX; Type 0: Not a Combination Product01/07/2021
    4NDC:81400-101-0466 in 1 BOX; Type 0: Not a Combination Product01/07/2021
    5NDC:81400-101-0572 in 1 BOX; Type 0: Not a Combination Product01/07/2021
    6NDC:81400-101-0684 in 1 BOX; Type 0: Not a Combination Product01/07/2021
    7NDC:81400-101-0790 in 1 BOX; Type 0: Not a Combination Product01/07/2021
    8NDC:81400-101-0896 in 1 BOX; Type 0: Not a Combination Product01/07/2021
    9NDC:81400-101-09102 in 1 BOX; Type 0: Not a Combination Product01/07/2021
    10NDC:81400-101-10108 in 1 BOX; Type 0: Not a Combination Product01/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/07/2021
    Labeler - Shenzhen Xing Ji Zhi Tong Technology Co.,Ltd (715076772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Xing Ji Zhi Tong Technology Co.,Ltd715076772manufacture(81400-101)