Aillia Fresh Sanitizer: Package Insert and Label Information

AILLIA FRESH SANITIZER- alcohol gel
MYUNG COSMETIC

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.

ACTIVE INGREDIENT

Ethyl alcohol 70.0 % v/v

INACTIVE INGREDIENTS

Water, Triethanolamine, Glycerin, Carbomer, Polysorbate 20, Tocopheryl Acetate, Perfume

PURPOSE

Antiseptic

WARNINGS

1.Do not use the product on the following areas:

Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)

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

3.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.
• Hypersensitivity symptoms, e.g. rash, erythema, itchiness, and edema
• Skin irritation symptoms

4.Other precautions
• For external use only (do not swallow).
• Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.
• Be careful not to inhale vapors in cases of extended or prolonged use. (Repeating inhaling of large amounts of ethanol vapor may cause irritation of the mucous membranes and headaches).
• If used repeatedly in the same area, care should be provided as the skin may become rough due to excessive oil removal.
• Do not use sealed bandages, cast bandages, or packs as they may cause irritation.
• Do not use this drug on the anal or vagina areas, or with hot packs, as it may cause irritation or chemical burns.
• Use only for the intended purposes.

5.Precautions for storage
• Keep away from direct sunlight and do not expose the product to heating devices or flame.
• After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.
• Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.

Dust or foreign substances may get on the product while using it.

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.

Uses

Uses:

Disinfection of hands and skin

Directions

Directions:

Take an appropriate amount on your hands and rub thoroughly to dry.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle
(click image for full-size original)

AILLIA FRESH SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74777-110
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 2.65 L in 3.79 L
Inactive Ingredients
Ingredient Name Strength
Water
TROLAMINE
Glycerin
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
Polysorbate 20
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74777-110-01 3.79 L in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/01/2020
Labeler — MYUNG COSMETIC (688222692)
Registrant — MYUNG COSMETIC (688222692)
Establishment
Name Address ID/FEI Operations
MYUNG COSMETIC 688222692 manufacture (74777-110)

Revised: 06/2020 MYUNG COSMETIC

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