RENUEE - dimethicone cream 
PMC TRADE, EXPORT AND IMPORT

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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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

image description

RENUEE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68973-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
SHEA BUTTER (UNII: K49155WL9Y)  
CAFFEINE (UNII: 3G6A5W338E)  
ALMOND OIL (UNII: 66YXD4DKO9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
D&C ORANGE NO. 11 (UNII: B16H36W4W4)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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: 7/2014
Document Id: b7c1dcd4-75d3-44c2-8344-ca5e0ddabddc
Set id: 3df61336-2508-4a28-baa2-ef4645042b19
Version: 1
Effective Time: 20140729
 
PMC TRADE, EXPORT AND IMPORT