FRESH AFTER VACANCE BODY SOOTHING

Dosage form: gel
Ingredients: Glycerin 30mL in 150mL
Labeler: NATURE REPUBLIC CO., LTD.
NDC Code: 51346-171

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 20%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Dipropylene Glycol, Betaine, Pentylene Glycol, Phenoxyethanol, Biosaccharide Gum-1, Carbomer, Arginine, PEG-60 Hydrogenated Castor Oil, Octyldodeceth-16, Fragrance(Parfum), Disodium EDTA, Butylene Glycol, Gaultheria Procumbens (Wintergreen) Leaf Extract, Propylene Glycol, Mimosa Tenuiflora Bark Extract, Sorbitol, Sodium Hydroxide, Citric Acid, Ethylhexylglycerin

PURPOSE

Purpose: Provides moisture to dry skin without leaving any sticky residue behind. It soothes scorched, sensitive skin and provides a refreshing sensation as it is quickly absorbed into 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: Apply to dry, irritated skin as often as needed to soothe the skin.

DOSAGE AND ADMINISTRATION

How to Use: Apply to dry, irritated skin as often as needed to soothe the skin.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

FRESH AFTER VACANCE BODY SOOTHING 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-171
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (Glycerin) Glycerin30 mL  in 150 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Dipropylene Glycol 
Betaine 
Pentylene Glycol 
Phenoxyethanol 
Packaging
#Item CodePackage Description
1NDC:51346-171-01150 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/2011
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIOperations
NATURE REPUBLIC CO., LTD.631172020manufacture(51346-171)

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)