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PLAGENTRA BABY BUBBLE WASH

Medically reviewed on Dec 8, 2017

Dosage form: aerosol, foam
Ingredients: Allantoin 1.25mg in 250mL
Labeler: C.A Pharm Co., Ltd.
NDC Code: 68988-080

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 Ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Potassium Laureth Phosphate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Glycerin, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Butylene Glycol, Phaseolus Radiatus Extract, Betula Platyphylla Japonica Bark Extract, Rumex Crispus Root Extract, Camellia Sinensis Leaf Extract, Betaine, Sodium Benzoate, Citric Acid, Disodium EDTA, Fragrance

PURPOSE

Purpose: Skin Portectant

WARNINGS

Warnings:
1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen :
1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.
2. Do not apply the product to wounds or skin with dermatitis such as eczema.
3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children.

INDICATIONS & USAGE

Indication and usage:
1) Tighten the lid after using it.
2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.
3) Use it in the morning or evening in the bath.

DOSAGE & ADMINISTRATION

Dosage and administration:
Take appropriate amount and gently apply to the body.
Then wash it up with.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLAGENTRA BABY BUBBLE WASH 
allantoin aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68988-080
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (ALLANTOIN) Allantoin1.25 mg  in 250 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:68988-080-01250 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2014
Labeler - C.A Pharm Co., Ltd. (688198385)
Registrant - C.A Pharm Co., Ltd. (688198385)
Establishment
NameAddressID/FEIOperations
C.A Pharm Co., Ltd.688198385manufacture(68988-080)

 
C.A Pharm Co., Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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