LEMON MYRTLE: Package Insert and Label Information

LEMON MYRTLE- macadamia seed oil glycereth-8 esters oil
Lemonmyrtle Korea 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.

macadamia seed oil

backhousia citriodora leaf oil (lemon myrtle leaf oil), lemon oil

for skin protectant

keep out of reach of the children

apply proper amount to the skin

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

for external use only

Label
(click image for full-size original)

LEMON MYRTLE
macadamia seed oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68960-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MACADAMIA SEED OIL GLYCERETH-8 ESTERS (MACADAMIA SEED OIL GLYCERETH-8 ESTERS) MACADAMIA SEED OIL GLYCERETH-8 ESTERS 85.006 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BACKHOUSIA CITRIODORA LEAF OIL
LEMON OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68960-0001-1 10 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/16/2016
Labeler — Lemonmyrtle Korea Co.,ltd (689605406)
Registrant — Lemonmyrtle Korea Co.,ltd (689605406)
Establishment
Name Address ID/FEI Operations
Lemonmyrtle Korea Co.,ltd 689605406 manufacture (68960-0001)

Revised: 02/2016 Lemonmyrtle Korea Co.,ltd

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