TRUEZYME BABY FACE AND BODY- glycerin lotion 
Truezyme 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

Active ingredient

Glycerin

Purpose

Skin protectant

For external use only

Inactive ingredients:

Sea Water, Caprylic/Capric Triglyceride, Propanediol, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter, etc.

Keep out of reach of children.

1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms.

1) If there are red spots, swelling, itchiness, or irritation

2) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight.

2. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

3. If it gets into eye, wash the eye with clean water immediately.

4. Those who are allergic to certain medicinal herb, such as pollen and tangerine, must stop using the product if they experience hypersensitivity.

5. Precautions on storage and handling

1) Make sure to close the cap after use.

2) Keep out of the reach of children.

3) Do not keep the product in a hot or cold place or a place getting direct sunlight.

1

TRUEZYME BABY FACE AND BODY 
glycerin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71076-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.008 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71076-0001-1200 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34710/01/2016
Labeler - Truezyme Co., Ltd. (693938262)
Establishment
NameAddressID/FEIBusiness Operations
Truezyme Co., Ltd.693938262manufacture(71076-0001)

Revised: 11/2016
Document Id: 414f78a2-77fd-0d28-e054-00144ff88e88
Set id: 414f16da-1644-5f0b-e054-00144ff8d46c
Version: 1
Effective Time: 20161114
 
Truezyme Co., Ltd.