OTC Medication Information: ATOMU

ATOMU- allantoin shampoo
CELIM BIOTECH 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.

ACTIVE INGREDIENT

Active ingredients: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Sodium laureth sulfate, Glycerin, Triethanolamine lauryl sulfate, Cocamidopropyl betaine, Lauramide DEA, Butylene glycol, 1,2-Hexanediol, Pinus densiflora leaf extract, Sodium chloride, Disodium laureth sulfosuccinate, Lonicera japonica (Honeysuckle) flower extract, Polyquaternium-7, Polyquaternium-10, Menthol, Lavandula angustifolia (Lavender) oil, Charcoal powder, Quercus acutissima wood vinegar extract, Royal jelly, Houttuynia cordata extract, Centella asiatica extract, Sesamum indicum (Sesame) seed extract, Ecklonia cava extract, Ulmus davidiana root extract, Cucumis sativus (Cucumber) fruit extract, Disodium EDTA, Lavandula angustifolia (Lavender) extract, Rosmarinus officinalis (Rosemary) extract, Thymus vulgaris (Thyme) extract, Mentha arvensis leaf extract, Borago officinalis extract, Salvia officinalis (Sage) leaf extract, Jasminum officinale (Jasmine) extract, Anthemis nobilis flower extract, Xanthan gum, Acorus calamus root extract, Perilla ocymoides leaf extract, Propolis extract

PURPOSE

Purpose: Skin(Scalp) Protectant

WARNINGS

Warnings:

1) If you develop symptoms such as red spots, swelling, or itching due to direct sunlight during or after using cosmetics, please consult a specialist.

2) Do not use the product on wounded areas.

3) Precautions for storage and handling

A- Keep away from the reach of children.

B- Store the product away from direct sunlight.

4) If the product gets into eyes, wash it off immediately.

5) Wash thoroughly with water after using the product as any product residual may cause hair loss or discoloration.

KEEP OUT OF REACH OF CHILDREN

Keep away from the reach of children

Uses

Uses:

The naturally fermented Atomu Essence with incorporated charcoal ingredients provides protection to sensitive scalps. It provides healthier scalp and cleaner hair with the extra charcoal ingredients to help reduce dry and dead skins.

Directions

Directions:

Take a moderate amount, make foam, and make bubble and massage your scalp to help absorption of effective ingredients and rinse off with water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle
(click image for full-size original)

ATOMU
allantoin shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72544-060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allantoin (ALLANTOIN) Allantoin 1.5 g in 300 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72544-060-01 300 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/01/2018
Labeler — CELIM BIOTECH CO.,LTD (694860906)
Registrant — CELIM BIOTECH CO.,LTD (694860906)
Establishment
Name Address ID/FEI Operations
Charming Cosmetics. Co. Ltd 689935740 manufacture (72544-060)

Revised: 07/2020 CELIM BIOTECH 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.

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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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