Truezyme Baby ShampooAndBody Wash

Manufacturer
Truezyme Co., Ltd.
Effective date
2016-11-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:00

Label at a glance#

ProductTruezyme Baby ShampooAndBody Wash
Active ingredientGLYCERIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Glycerin

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

WARNINGS

WARNINGS SECTION

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.

INDICATIONS & USAGE SECTION

- 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

For the external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71076-0002-12020-01-31C16284748780-19d75b9d0-6133-f424-e053-dadaa90a57ce41652c38-145f-062b-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71076-0002-1Truezyme Baby ShampooAndBody Wash300 mL in 1 BOTTLE, PUMPLIQUID3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71076-0002TRUEZYME BABY SHAMPOOANDBODY WASH (GLYCERIN) LIQUID [TRUEZYME CO., LTD.]1Legacy NDC, 1 package rows20161117_41652c38-145f-062b-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71076-000271076-0002-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PANTHENOLWV9CM0O67ZIACT
GLYCERINPDC6A3C0OXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
41652c38-1460-062b-e054-00144ff8d46c41652c38-145f-062b-e054-00144ff8d46c2016-11-15WarningsExact identifier
spl id: 41652c38-1460-062b-e054-00144ff8d46c
spl set id: 41652c38-145f-062b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.