MEDIFENSE CLEAN HAND MIST GREENERY BOUQUET: Package Insert and Label Information

MEDIFENSE CLEAN HAND MIST GREENERY BOUQUET- alcohol spray
L&P Cosmetic Co., Ltd.

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(s)

ALCOHOL 70.0% v/v

Purpose

ANTISEPTIC

Warnings

For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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.

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions

• For optimal results, place enough product on hands and rub hands together for 30 seconds.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

1,2-Hexanediol, 3-O-Ethyl Ascorbic Acid, Benzyl Salicylate, Butylphenyl Methylpropional, Chamomilla Recutita (Matricaria) Flower Extract, Citric acid, Cymbopogon Schoenanthus Extract, Eugenol, Fragrance, Glycerin, Lavandula Angustifolia (Lavender) Flower Extract, Linalool, Panthenol, PEG-40 Hydrogenated Castor Oil, PEG-60 Hydrogenated Castor Oil, Rosmarinus Officinalis (Rosemary) Extract, Saccharide Isomerate, Salvia Officinalis (Sage) Leaf Extract, Sodium Citrate, Tocopheryl Acetate, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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MEDIFENSE CLEAN HAND MIST GREENERY BOUQUET
alcohol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74005-040
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 21 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
1,2-Hexanediol
3-O-Ethyl Ascorbic Acid
Benzyl Salicylate
Butylphenyl Methylpropional
CHAMOMILE
CITRIC ACID MONOHYDRATE
CYMBOPOGON SCHOENANTHUS TOP
Eugenol
Glycerin
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER
LINALOOL, (+/-)-
Panthenol
POLYOXYL 40 HYDROGENATED CASTOR OIL
ROSEMARY
Saccharide Isomerate
SAGE
SODIUM CITRATE, UNSPECIFIED FORM
.ALPHA.-TOCOPHEROL ACETATE
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74005-040-01 30 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 11/01/2020
Labeler — L&P Cosmetic Co., Ltd. (557821713)
Registrant — L&P Cosmetic Co., Ltd. (557821713)
Establishment
Name Address ID/FEI Operations
E.CIS COSMETIC.,Co.Ltd 689846270 manufacture (74005-040)

Revised: 11/2020 L&P Cosmetic Co., Ltd.

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