GOONGSECRET CALMING BATH- allantoin powder 
Zero to Seven Inc.

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.

----------

Drug Facts

ACTIVE INGREDIENT

Active ingredient: ALLANTOIN 0.55%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Viscum Album (Mistletoe) Fruit Extract, Vanilla Planifolia Fruit Extract, Tocopheryl Acetate, Squalane, Sophora Japonica Root Extract, Sodium Sulfate, Sodium Bicarbonate, Salix Alba (Willow) Bark Extract, Rose Flower Oil, Prunus Persica (Peach) Leaf Extract, Prunus Mume Flower Extract, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Polydecene, Phellodendron Amurense Bark Extract, Pelargonium Graveolens Flower Oil, Olea Europaea (Olive) Fruit Oil, Myrtus Communis Oil, Morus Alba Stem Extract, Lithospermum Erythrorhizon Root Extract, Lavandula Angustifolia (Lavender) Oil, Jasminum Officinale (Jasmine) Oil, Houttuynia Cordata Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Glyceryl Caprylate, Ferula Galbaniflua (Galbanum) Resin Oil, Dipotassium Glycyrrhizate,
Copaifera Officinalis (Balsam Copaiba) Resin, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Chrysanthemum Morifolium Flower Extract, Centella Asiatica Leaf Extract, Cedrus Atlantica Bark Oil, Camellia Japonica seed Extract, Betaine, Artemisia Princeps Leaf Extract, Artemisia Absinthium Extract, Angelica Acutiloba Root Extract

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:
1. Stop using when this product irritates your skin. (When skin rash, swelling, and itchiness occurs.)
2. Keep out of reach of children.
3. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of reach of children

INDICATIONS & USAGE

Indication and usage:
- Pour 1 pack into warm bath and stir to dissolve gently.
- Gently rinse with warm water after a bath.

DOSAGE & ADMINISTRATION

Dosage and administration:
- For babies: with stirring in 5g (half a pack) and around 30-40L of warm water on the baby bathtup, take a bath for 5 mins
- For children : with stirring in  10g (a pack) and around 100L of warm water on the bathtup, take a bath for 10-15 mins
- For adult : with stirring in 20g (two packs) and around 200L of warm water on the bathtup, take a bath for 15-20 mins

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

GOONGSECRET CALMING BATH 
allantoin powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43319-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.055 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
VISCUM ALBUM FRUIT (UNII: P83EQ521R3)  
VANILLA (UNII: Q74T35078H)  
SQUALANE (UNII: GW89575KF9)  
STYPHNOLOBIUM JAPONICUM ROOT (UNII: LAH7966318)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PRUNUS PERSICA LEAF (UNII: VN3501T41P)  
PRUNUS MUME FLOWER (UNII: 2N8872050J)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
MYRTLE LEAF OIL (UNII: 4ZP3Q1OY08)  
MORUS ALBA STEM (UNII: 05Y42QCG2T)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE OIL (UNII: AKN3KSD11B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43319-030-0110 g in 1 CARTON; Type 0: Not a Combination Product03/01/201212/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/201212/31/2014
Labeler - Zero to Seven Inc. (557805132)
Registrant - Zero to Seven Inc. (557805132)
Establishment
NameAddressID/FEIBusiness Operations
Zero to Seven Inc.557805132manufacture(43319-030)

Revised: 8/2017
 
Zero to Seven Inc.