Volcanic Pore Cleansing Patch: Package Insert and Label Information

VOLCANIC PORE CLEANSING PATCH- witch hazel patch
AMI Cosmetic 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.

Volcanic Ash, Hamamelis Virginiana (Witch Hazel) Extract

Water, Sea Water, Bambusa Vulgaris Water, etc.

Skin Protectant — Whitening & Anti-Wrinkle

keep out of reach of the children

  1. After face wash, wet the nose area and dry your hands.
  2. Tear off the films from both sides of the patch and place smoother side on the nose area that needs black head care from the center firmly toward the edge.
  3. After about 10~15 minutes when the patch is fully dired and hardens, tear it off from the edge toward the center.

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

for external use only

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(click image for full-size original)

VOLCANIC PORE CLEANSING PATCH
hamamelis virginiana (witch hazel) extract patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59535-0231
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL 0.01 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59535-0231-2 8 POUCH in 1 PACKAGE contains a POUCH (59535-0231-1)
1 NDC:59535-0231-1 1 g in 1 POUCH This package is contained within the PACKAGE (59535-0231-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2016
Labeler — AMI Cosmetic Co.,Ltd. (631055345)
Registrant — AMI Cosmetic Co.,Ltd. (631055345)
Establishment
Name Address ID/FEI Operations
AMI Cosmetic Co.,Ltd. 631055345 manufacture (59535-0231)

Revised: 08/2016 AMI Cosmetic Co.,Ltd.

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