TRUEZYME BABY FACE AND BODY- glycerin lotion

Truezyme Baby Face and Body by

Drug Labeling and Warnings

Truezyme Baby Face and Body by is a Otc medication manufactured, distributed, or labeled by Truezyme Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Glycerin

Purpose

Skin protectant

DOSAGE & ADMINISTRATION

For external use only

INDICATIONS & USAGE

• Apply to baby's face and body evenly after a bath or washing.

• Apply to dry, rough-textured area repeatedly.

• Use with Truezyme Baby Shampoo & Body Wash for better results.

Inactive ingredients:

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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. 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRUEZYME BABY FACE AND BODY 
glycerin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71076-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.008 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71076-0001-1	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	10/01/2016

Labeler - Truezyme Co., Ltd. (693938262)

Establishment
Name	Address	ID/FEI	Business Operations
Truezyme Co., Ltd.		693938262	manufacture(71076-0001)