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Renuee

Dosage form: cream
Ingredients: DIMETHICONE 2g in 100g
Labeler: PMC TRADE, EXPORT AND IMPORT
NDC Code: 68973-002

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

Dimethicone 2%

Purpose

Skin protectant

Use

■ helps prevent, temporarily protects and relieve chafed, chapped, or cracked skin

Warnings

For external use only

When using this product

■ do not get into eyes

Stop use and ask a doctor if

■ condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

If pregnant or breast feeding

ask a health professional before use

Keep out of reach of children

to avoid accidental poisoning, in case of accidental ingestion contact a doctor or Poison Control Center immediately.

Directions

apply as needed

Inactive Ingredients

Deionized Water, Aloe Vera (Aloe Barbadensis) Leaf Gel, Gotu Kola (Centella Asiatica) Extract, Seaweed (Fucus Vesiculosus) Extract, Ginkgo biloba, Shea (Butyrospermum Parkii) Butter, Cocoa (Theobroma Cacao) Butter, Caffeine, Sweet Almond (Prunus Amygdalus Dulcis) Oil, Xanthan Gum, Tetrasodium EDTA, Elderberry (Sambucus Nigra) Extract, Jojoba Esters, Glycerin, Green Tea (Camellia Sinensis) Leaf Extract, Horsetail (Equisetum Arvense) Extract, Hydrolyzed Wheat Proteins, Tocopheryl Acetate (Vitamin E), Acrylates Copolymer, Propylene Glycol, SD-Alcohol 40B, Triethanolamine, Fragrance, DMDM Hydantoin, Caramel Color, D&C Orange #4, FD&C Yellow #5

Product Label

RENUEE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68973-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE VERA LEAF 
CENTELLA ASIATICA 
FUCUS VESICULOSUS 
GINKGO BILOBA WHOLE 
SHEA BUTTER 
CAFFEINE 
ALMOND OIL 
XANTHAN GUM 
EDETATE SODIUM 
SAMBUCUS NIGRA FLOWERING TOP 
JOJOBA OIL, RANDOMIZED 
GLYCERIN 
GREEN TEA LEAF 
EQUISETUM ARVENSE BRANCH 
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) 
ALPHA-TOCOPHEROL ACETATE 
PROPYLENE GLYCOL 
TROLAMINE 
DMDM HYDANTOIN 
D&C ORANGE NO. 11 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:68973-002-9090 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/15/2014
Labeler - PMC TRADE, EXPORT AND IMPORT (179635003)

Revised: 07/2014
 
PMC TRADE, EXPORT AND IMPORT

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.

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