BDR RE-VITAL PH PURE HARMONY CARE SOOTHING SKIN OPTIMIZER- panthenol liquid

bdr Re-vital PH pure harmony care soothing skin optimizer by

Drug Labeling and Warnings

bdr Re-vital PH pure harmony care soothing skin optimizer by is a Otc medication manufactured, distributed, or labeled by Goldeneye Permanent System Gmbh Germany, Hanaim International Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Pantheno (0.75%)

Purpose

skin protectant

Keep out of reach of children

Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Warnings

For external use only
Do not use when Your skin is red, inflamed, irritated or painful
When using this product
 Do not apply on other parts of the body
 Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
 Do not apply directly to wound or open cut.
Stop use and ask doctor if rash or irritation on skin develops and lasts.
Keep out of reach of children
 Do not swallow. In case of accidental ingestion, seek professional assistance.
Store at room temperature

Uses

Keeps skin smooth, pure, and balanced for sensitive, irritated, or red skin. Recommended for the delicate eye area.

Directions

Apply morning and evening after cleansing.

Inactive Ingredients

AQUA (WATER), CAPRYLIC/CAPRI C TRIGLYCERI DE, OCTYLDODECANOL, ISODECYL NEOPENTANOATE, GLYCERIN, GLYCERYL STEARATE CITRATE, SQUALANE, SUCROSE STEARATE, BETAINE, VITIS VINIFERA (GRAPE) SEED OIL, DICAPRYLYL ETHER, THEOBROMA GRANDIFLORUM SEED BUTTER ( CUPUACU BUTTER), CETEARYL ALCOHOL, ARGANIA SPINOSA OIL (ARGANIA SPINOSA KERNEL OIL) [ARGANOIL], RIBES NIGRUM SEED OIL, PANTHENOL, PHENOXYETHANOL, MACADAMIA TERNIFOLIA SEED OIL, SODIUM CARBOMER, SODIUM STEAROYL GLUTAMATE, BUTYLENE GLYCOL, LACTIC ACID, GLYCINE SOJA (SOYBEAN) OIL, PERSEA GRATISSIMA (AVOCADO) OIL, GLYCINE SOJA (SOYBEAN) STEROL, XANTHAN GUM, PARFUM (FRAGRANCE), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, BENZOIC ACID, ALLANTOIN, UBIQUINONE (Q10), SODIUM HYALURONATE, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, DEHYDROACETIC ACID, TOCOPHEROL, ASCORBYL PALMITATE, LECITHIN, CARDIOSPERMUM HALICACABUM FLOWER/LEAFNINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM PHYTATE, HYDROGENATED PALM GLYCERIDES CITRATE, CARBOMER, COCO-GLUCOSIDE, POTASSIUM SORBATE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, ALCOHOL, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTI DE-7

bdr Re-vital PH pure harmony care soothing skin optimizer

INGREDIENTS AND APPEARANCE

BDR RE-VITAL PH PURE HARMONY CARE SOOTHING SKIN OPTIMIZER 
panthenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71056-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.375   in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OCTYLDODECANOL (UNII: 461N1O614Y)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
SQUALANE (UNII: GW89575KF9)
SUCROSE STEARATE (UNII: 274KW0O50M)
BETAINE (UNII: 3SCV180C9W)
GRAPE SEED OIL (UNII: 930MLC8XGG)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARGAN OIL (UNII: 4V59G5UW9X)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MACADAMIA OIL (UNII: 515610SU8C)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LACTIC ACID (UNII: 33X04XA5AT)
SOYBEAN OIL (UNII: 241ATL177A)
AVOCADO OIL (UNII: 6VNO72PFC1)
SOY STEROL (UNII: PL360EPO9J)
XANTHAN GUM (UNII: TTV12P4NEE)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ALLANTOIN (UNII: 344S277G0Z)
UBIDECARENONE (UNII: EJ27X76M46)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOYBEAN (UNII: L7HT8F1ZOD)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
PHYTATE SODIUM (UNII: 88496G1ERL)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
COCO GLUCOSIDE (UNII: ICS790225B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ROSEMARY (UNII: IJ67X351P9)
ALCOHOL (UNII: 3K9958V90M)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71056-108-02	1 in 1 PACKAGE	11/17/2016
1	NDC: 71056-108-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/17/2016

Labeler - Hanaim International Llc (070319425)

Registrant - Hanaim International Llc (070319425)

Establishment
Name	Address	ID/FEI	Business Operations
Hanaim International Llc		070319425	relabel(71056-108)

Establishment
Name	Address	ID/FEI	Business Operations
Goldeneye Permanent System Gmbh Germany		329178144	manufacture(71056-108)