RE-CHARGE PH- panthenol lotion

Re-charge PH by

Drug Labeling and Warnings

Re-charge PH by is a Otc medication manufactured, distributed, or labeled by Goldeneye Permanent System GmbH, Hanaim International LLC, Goldeneye Permanent System Gmbh. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

Apply one full pump of the lotion evenly onto face avoiding eye areas.

ACTIVE INGREDIENT

Panthenol (1.5%)............skin protectant

ASK DOCTOR

If irritation persists after application then stop use immiediatly and see a doctor.

KEEP OUT OF REACH OF CHILDREN

If accidently ingested then see a doctor immediately. If it gets into eyes rinse out and see a doctor.

PURPOSE

To soothe irritated and inflamed skin. Control excessive oil secretion. To protect and replenish skin barrier while providing ample long lasting hydration to the skin.

QUESTIONS

For comments and questions call 201 917 5858.

WARNINGS

Stop use if redness or irritation is persistant. See a doctor if condition worsens after you have stopped using the product.

INDICATIONS & USAGE

Use on clean and dry skin, morning and night after using a tonic.

INACTIVE INGREDIENT

AQUA (WATER), GLYCERIN, BETAINE, PROPANEDIOL, PHENOXYETHANOL, HYDROXYETHYLCELLULOSE,
ALLANTOIN, SODIUM LACTATE, SODIUM PCA, SODIUM HYALURONATE, BENZOIC ACID, DEHYDROACETIC ACID, SODIUM PHYTATE,
MACLURA COCHINCHINENSIS LEAF PRENYLFLAVONOIDS, SODIUM HYDROXIDE, INOSITOL, LACTIC ACID, NIACINAMIDE, FRUCTOSE,
GLYCINE, UREA, SODIUM BENZOATE, ALCOHOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RE-CHARGE PH 
panthenol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71056-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
INOSITOL (UNII: 4L6452S749)
FRUCTOSE (UNII: 6YSS42VSEV)
UREA (UNII: 8W8T17847W)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
MACLURA COCHINCHINENSIS WHOLE (UNII: X083FY34PH)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCINE (UNII: TE7660XO1C)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
SODIUM LACTATE (UNII: TU7HW0W0QT)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
PHYTATE SODIUM (UNII: 88496G1ERL)
LACTIC ACID (UNII: 33X04XA5AT)
BETAINE (UNII: 3SCV180C9W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71056-120-01	1 in 1 BOX	02/01/2020
1		1 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2020

Labeler - Goldeneye Permanent System GmbH (329178144)

Registrant - Hanaim International LLC (070319425)

Establishment
Name	Address	ID/FEI	Business Operations
Goldeneye Permanent System Gmbh		329178144	manufacture(71056-120) , label(71056-120)