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Over the Counter Medications

BEEVENOM SLEEPING MASK: Package Insert and Label Information

BEEVENOM SLEEPING MASK- glycerin cream
NATURE REPUBLIC 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

Active Ingredient: Glycerin 20%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Dipropylene Glycol, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phenoxyethanol, Bee Venom, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-6, Dimethiconol, PEG-60 Hydrogenated Castor Oil, Silica, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Squalane, Octyldodeceth-16, Caprylyl Glycol, Gelatin, Alcohol, Oryza Sativa (Rice) Bran Oil, Ascorbyl Tetraisopalmitate, Mica, Iron Oxides, Titanium Dioxide, Dipotassium Glycyrrhizate, Caffeine, Olea Europaea (Olive) Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Pinus Sylvestris Leaf Oil, Cananga Odorata Flower Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Pelargonium Graveolens Flower Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Ubiquinone, Polydecene, Viscum Album (Mistletoe) Fruit Extract, Camellia Japonica Flower Extract, Phospholipids, Silver, Tocopheryl Acetate, Glyceryl Arachidonate, Glyceryl Linolenate, Glyceryl Linoleate, BHT, Salicylic Acid, Ascorbic Acid

PURPOSE

Purpose: Formulated with 75% bee venom complex, this sleeping pack soothes sensitive, reddish skin.

WARNINGS

Cautions:
For external use only.
Avoid contact with eyes and mouth.
Discontinue use if signs of irritation or rash appear.
Keep out of reach of children.
Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

How to Use: At the last step of your skin care, apply an appropriate amount to the entire face avoiding eye area, leave for about 15 minutes to be absorbed into the skin. Use once or twice a week.

DOSAGE AND ADMINISTRATION

How to Use: At the last step of your skin care, apply an appropriate amount to the entire face avoiding eye area, leave for about 15 minutes to be absorbed into the skin. Use once or twice a week.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

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

BEEVENOM SLEEPING MASK
glycerin cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51346-167
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Glycerin (Glycerin) Glycerin 18 g in 90 mL
Inactive Ingredients
Ingredient Name Strength
Water
Dipropylene Glycol
Butylene Glycol
Phenoxyethanol
Squalane
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51346-167-01 90 mL in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 11/01/2011
Labeler — NATURE REPUBLIC CO., LTD. (631172020)
Registrant — NATURE REPUBLIC CO., LTD. (631172020)
Establishment
Name Address ID/FEI Operations
NATURE REPUBLIC CO., LTD. 631172020 manufacture (51346-167)

Revised: 09/2012 NATURE REPUBLIC CO., LTD.