TRUEZYME BABY SHAMPOOANDBODY WASH- glycerin liquid 
Truezyme 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.

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Glycerin

Cleanse, moisturize, and smoothen sensitive baby's skin gently.

Sea Water, Water, Lauryl Glucoside, Decyl Glucoside, Pentylene Glycol, Laminaria Japonica Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Panthenol, etc.

WARNINGS

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. Wash away with water enough after use since not enough rinsing can lead to hair loss or discoloration.

5. Those who are allergic to certain medicinal herb, such as pollen and tangerine, must stop using the product if they experience hypersensitivity. 6. 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.

- Wet the whole body and lather well on a shower sponge, a towel, or hands and massage the whole body gently and wash away with water cleanly.

- For a bath, you can enjoy a refreshing enzymatic bath by lathering enough in warm water.

* Shake well before use.

Keep out of reach of children.

For the external use only

1

TRUEZYME BABY SHAMPOOANDBODY WASH 
glycerin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71076-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PANTHENOL (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71076-0002-1300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/2016
Labeler - Truezyme Co., Ltd. (693938262)
Establishment
NameAddressID/FEIBusiness Operations
Truezyme Co., Ltd.693938262manufacture(71076-0002)

Revised: 11/2016
Document Id: 41652c38-1460-062b-e054-00144ff8d46c
Set id: 41652c38-145f-062b-e054-00144ff8d46c
Version: 1
Effective Time: 20161115
 
Truezyme Co., Ltd.