TROUBLE CLEAR SPOT 1.2CM- carboxymethylcellulose sodium patch 
SKINFOOD CO.,LTD.

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.

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ACTIVE INGREDIENT

Active ingredient: Cellulose Gum 35.9%

INACTIVE INGREDIENT

Inactive ingredients: Polyisobutylene, Petroleum resin, Stylene Isoprene Stylene block copolymer, Polyurethane Film, Tetrakis methane, Liquid Paraffin

PURPOSE

Purpose: Protecting wounds

WARNINGS

Warnings:

1. Apply the product to a slightly bigger than the affected area.

2. Do not use on children younger than three years old since the product has to be left on skin for a long time and has strong adhesion.

3. Do not use for patients with healing disorders, such as wounds with heavy bleeding, infected wounds, patients with diabetes or blood circulation diseases. *What are the symptoms of infection? Symptoms of infection include unclear fluid from the wound, when redness, swelling, pain increases, and when a foul smell continues even after washing the affected area.

4. Please consult a physician for the following symptoms: - When the affected area feels warm or swells with redness. - If you have allergies or sensitive skin, consult a physician or a pharmacist before using the product. - If the wound doesn't heal within four days.

5. This product is for one-time use. Do not reuse. If the packaging is damaged or open, sterilizing is not guaranteed. Use immediately upon opening the product, make sure to close the packaging after use. Do not use if the packaging is damaged.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Use

Use: Thoroughly rinse the affected area with water. Remove the film from the back of the product then apply the product to the affected area. Replace the product when the product swells because of exudation from the wound. Replace the product once a day, or more than once a day.

Directions

Directions: Thoroughly cleanse the wound then completely dry the affected area. Do not apply any ointment, apply the product to an area slightly bigger that the affected area. The product absorbs exudation, heals the wound and the swelling goes down as the wound heals. Do not replace the product frequently so it can absorb exudation from the wound. Replace the product once a day, or more than once a day, until the wound is healed and the swelling goes down.

Directions for removing the product: Hold the tip of the product, and gently pull the product parallel to the surface. If you remove the product forcefully, you may damage the renewed skin cells. If you cannot remove the product easily, apply warm water to soften the product then gently remove.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

TROUBLE CLEAR SPOT  1.2CM
carboxymethylcellulose sodium patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM18.12 mg  in 9 
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-051-019 in 1 CARTON; Type 0: Not a Combination Product02/01/201503/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/201503/01/2017
Labeler - SKINFOOD CO.,LTD. (690324173)
Registrant - SKINFOOD CO.,LTD. (690324173)
Establishment
NameAddressID/FEIBusiness Operations
SKINFOOD CO.,LTD.690324173repack(76214-051)
Establishment
NameAddressID/FEIBusiness Operations
Young Chemical Co., Ltd.689456171manufacture(76214-051)

Revised: 7/2017
 
SKINFOOD CO.,LTD.