BABLAB SUPER CLEAN CALMING CLEANSING BALM by FICC Co., Ltd. / Intercos Korea Inc.

BABLAB SUPER CLEAN CALMING CLEANSING BALM by

Drug Labeling and Warnings

BABLAB SUPER CLEAN CALMING CLEANSING BALM by is a Otc medication manufactured, distributed, or labeled by FICC Co., Ltd., Intercos Korea Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BABLAB SUPER CLEAN CALMING CLEANSING BALM- sodium bicarbonate cream 
FICC 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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ACTIVE INGREDIENT

SODIUM BICARBONATE 5.0%

INACTIVE INGREDIENTS

ETHYLHEXYL STEARATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, BEESWAX (CERA ALBA), SORBETH-30 TETRAOLEATE, SILICA DIMETHYL SILYLATE, SORBITAN SESQUIOLEATE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, PELARGONIUM GRAVEOLENS FLOWER OIL, MELIA AZADIRACHTA LEAF EXTRACT, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, MELIA AZADIRACHTA FLOWER EXTRACT, COCCINIA INDICA FRUIT EXTRACT, MENTHA ARVENSIS FLOWER/LEAF/STEM EXTRACT, CITRUS TANGERINA (TANGERINE) PEEL OIL, SOLANUM MELONGENA (EGGPLANT) FRUIT EXTRACT, ALOE BARBADENSIS FLOWER EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, OCIMUM SANCTUM LEAF EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, CORALLINA OFFICINALIS EXTRACT, WATER (AQUA), BUTYLENE GLYCOL, GLUCONOLACTONE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF WATER, GLYCERIN, HOUTTUYNIA CORDATA EXTRACT, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, HIBISCUS SABDARIFFA FLOWER EXTRACT, ARTEMISIA PRINCEPS LEAF EXTRACT, 1,2-HEXANEDIOL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CENTELLA ASIATICA EXTRACT, SAPINDUS TRIFOLIATUS FRUIT EXTRACT, ALTHAEA ROSEA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, TARAXACUM OFFICINALE (DANDELION) EXTRACT, PERILLA OCYMOIDES LEAF EXTRACT, PANAX NOTOGINSENG EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) EXTRACT, LINALOOL, LIMONENE, CITRONELLOL

PURPOSE

PH Adjuster

WARNINGS

For external use only
Consult a specialist if there are abnormal symptoms or side effects such as redness, swelling or itchiness due to direct sunlight during or after use.
Avoid using on wounded areas.
Be careful of grains get into eye.
Wash grains with water when they get into eye and consult a specialist if there is any abnormality.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Uses

■ Helps brighten skin tone

Directions

■ Apply an appropriate amount onto dry face and massage avoiding the eye area until it turns into oil.
■ Emulsify by using water and rinse thoroughly with lukewarm water.

Other Information

■ Keep away from direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BABLAB SUPER CLEAN CALMING CLEANSING BALM 
sodium bicarbonate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81647-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	4.5 g  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81647-140-02	1 in 1 CARTON	05/01/2021	10/01/2022
1	NDC: 81647-140-01	90 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2021	10/01/2022

Labeler - FICC Co., Ltd. (695721074)

Registrant - FICC Co., Ltd. (695721074)

Establishment
Name	Address	ID/FEI	Business Operations
Intercos Korea Inc.		694526100	manufacture(81647-140)

Revised: 10/2023

Document Id: e49f90df-bd40-4fd7-98d1-387115af64b6

34390-5

Set id: 7e51dc7f-dbdc-4283-bc3b-20f522bf94aa

Version: 2

Effective Time: 20231016