RENUEE- dimethicone cream

Renuee by

Drug Labeling and Warnings

Renuee by is a Otc medication manufactured, distributed, or labeled by PMC TRADE, EXPORT AND IMPORT . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

RENUEE 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68973-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68973-002-90	90 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/15/2014

Labeler - PMC TRADE, EXPORT AND IMPORT (179635003)