BULGARIAN ROSE- glycerin lotion 
AMI 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.

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Drug Facts

Glycerin

Water, Butylene Glycol, Etc

Skin Protectant - Anti Wrinkle, brightening

keep out of reach of the children

After face wash, apply suitable toner for your skin type. Take moderate amount of this product at the step of applying cream and gently pat for better absorption

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

BULGARIAN ROSE 
glycerin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59535-0274
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6.502 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59535-0274-1120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/24/201803/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/24/201803/28/2019
Labeler - AMI Cosmetic Co.,Ltd. (631055345)
Registrant - AMI Cosmetic Co.,Ltd. (631055345)
Establishment
NameAddressID/FEIBusiness Operations
AMI Cosmetic Co.,Ltd.631055345relabel(59535-0274) , manufacture(59535-0274)

Revised: 3/2019
 
AMI Cosmetic Co.,Ltd.