OTC Medication Information: CellExosome HE HR

CELLEXOSOME HE HR- niacinamide liquid
PROSTEMICS 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.

ACTIVE INGREDIENT

Active ingredients: Niacinamide 3.0%

INACTIVE INGREDIENT

Inactive ingredients:

[Powder] HUMAN ADIPOSE DERIVED STEM CELL CONDITIONED MEDIA, Asparagus Officinalis Extract
[Solvent] Water, Panthenol, 1,2-Hexanediol, Hydroxyacetophenone, Sodium Hyaluronate

PURPOSE

Purpose: Hair elasticity

WARNINGS

Warnings:
For external use only
1. Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product
2. Do not apply to open wounds.
3. Avoid contact with eyes.
Storage and handling
4. Replace the cap after use
5. Keep out of reach of children.
6. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN SECTION

Uses

Uses:

Improves effects of hair elasticity.

Directions

Directions:

■ Put solvent into the powder ampoule and shake gently enough to dissolve the mixture.
■ Take proper amount and gently apply onto the scalp.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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CELLEXOSOME HE HR
niacinamide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62041-310
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Niacinamide (NIACINAMIDE) Niacinamide 0.18 g in 6 mL
Inactive Ingredients
Ingredient Name Strength
Water
Panthenol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62041-310-02 1 CONTAINER in 1 CARTON contains a CONTAINER (62041-310-01)
1 NDC:62041-310-01 6 mL in 1 CONTAINER This package is contained within the CARTON (62041-310-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/01/2020
Labeler — PROSTEMICS Co., Ltd. (689605919)
Registrant — PROSTEMICS Co., Ltd. (689605919)
Establishment
Name Address ID/FEI Operations
Prostemics Co., Ltd. Factory 695687674 manufacture (62041-310)

Revised: 02/2020 PROSTEMICS Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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