THE QUEEN ROSE- witch hazel liquid 
LaLa 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.

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ACTIVE INGREDIENT

Active ingredient: Witch Hazel 0.1%

INACTIVE INGREDIENT

Inactive ingredients:
ANISE OIL, BERGAMOT OIL, CHAMOMILLE ROMAN OIL, GERANIUM OIL, LAVENDER OIL, LEMON OIL, ORANGE OIL, OLIVE OIL, ROSE BULGARIA OIL, YLANG YLANG OIL, SUN FLOWER OIL, LEONURUS SIBIRICUS EXTRACT, ANGELICA GIGAS ROOT EXTRACT, ARTEMISIA PRINCEPS LEAF EXTRACT, CHRYSANTHEMUM ZAWADSKII EXTRACT

PURPOSE

Purpose: Skin Protectant, Fragrance

WARNINGS

Warnings:
In case of having following symptoms after using this, you're advised to stop using it immediately.
If you keep using it, the symptoms will get worse and need to consult a dermatologist.
1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
You are banned to use it on the part where you have a scar, eczema, or dermatitis.
In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of reach of babies and children.

INDICATIONS AND USAGE

Indication and usage:
Tighten the lid after using it.
Keep it out of infants or children's reach.
Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

DOSAGE AND ADMINISTRATION

Dosage and administration:
Tighten the lid after using it.
Keep it out of infants or children's reach.
Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

THE QUEEN ROSE 
witch hazel liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55885-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.005 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANISE OIL (UNII: 6Y89129C8H)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55885-010-015 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/2012
Labeler - LaLa Co., Ltd. (688380004)
Registrant - LaLa Co., Ltd. (688380004)
Establishment
NameAddressID/FEIBusiness Operations
LaLa Co., Ltd.688380004manufacture(55885-010)

Revised: 2/2013
Document Id: b5134f32-b069-4536-a59f-f2627a549933
Set id: 90258c90-d9bd-4b9c-8542-f57e716ab433
Version: 1
Effective Time: 20130220
 
LaLa Co., Ltd.