SOOTHING AND MOISTURE ALOE VERA 90 PERCENT TONER: Package Insert and Label Information

SOOTHING AND MOISTURE ALOE VERA 90 PERCENT TONER- glycerin cream
NATURE REPUBLIC 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 Ingredient: Glycerin 22.5%

INACTIVE INGREDIENT

Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Ethyl Hexanediol, Phenoxyethanol, Butylene Glycol, Alcohol Denat., PEG-40 Hydrogenated Castor Oil, PPG-26-Buteth-26, Sea Water, Caprylyl Glycol, Fragrance(Parfum), Xanthan Gum, Sodium Hyaluronate, Polyquaternium-51, Water, Sodium Polyacrylate, PVM/MA Copolymer

PURPOSE

Purpose: Soothes and moisturizes the skin.

WARNINGS

Cautions:
For external use only.
Avoid contact with eyes and mouth.
Discontinue use if signs of irritation or rash appear.
Keep out of reach of children.
Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

How to Use: After washing, gently spread over face.

DOSAGE AND ADMINISTRATION

How to Use: After washing, gently spread over face.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

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SOOTHING AND MOISTURE ALOE VERA 90 PERCENT TONER
glycerin cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51346-141
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Glycerin (Glycerin) Glycerin 36 g in 160 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
Phenoxyethanol
Butylene Glycol
Water
Caprylyl Glycol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51346-141-01 160 mL in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/01/2011
Labeler — NATURE REPUBLIC CO., LTD. (631172020)
Registrant — NATURE REPUBLIC CO., LTD. (631172020)
Establishment
Name Address ID/FEI Operations
NATURE REPUBLIC CO., LTD. 631172020 manufacture (51346-141)

Revised: 09/2012 NATURE REPUBLIC CO., LTD.

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