BDR RE-FRESH GEL MASK FACE- allantoin patch

bdr Re-fresh gel mask face by

Drug Labeling and Warnings

bdr Re-fresh gel mask face by is a Otc medication manufactured, distributed, or labeled by Hanaim International Llc, Goldeneye Permanent System Gmbh Germany. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Allantoin (0.2%)

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

Moisturizes and helps gently calm stressed skin. Keep skin smooth and soft. Wrinkle care.

Directions

Apply on cleansed face for 10-15 minutes. After removing mask no need cleansing is required. Single use only.

Inactive Ingredients

AQUA (WATER), GLYCERIN, PROPYLENE GLYCOL, CORN GLUTEN AMINO ACIDS, COLLAGEN, ALLANTOIN, HYALURONIC ACID, PORTULACA OLERACEA EXTRACT, SH­ OLIGOPEPTIDE-1, UBIQUINONE (Q10), MICA, PHENOXYETHANOL, PARFUM

bdr Re-fresh gel mask face

INGREDIENTS AND APPEARANCE

BDR RE-FRESH GEL MASK FACE 
allantoin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71056-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.12 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINO ACIDS, CORN GLUTEN (UNII: 0540V8ZD7V)
BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)
HYALURONIC ACID (UNII: S270N0TRQY)
PURSLANE (UNII: M6S840WXG5)
UBIDECARENONE (UNII: EJ27X76M46)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71056-112-02	5 in 1 PACKAGE	11/18/2016
1	NDC: 71056-112-01	60 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/18/2016

Labeler - Hanaim International Llc (070319425)

Registrant - Hanaim International Llc (070319425)

Establishment
Name	Address	ID/FEI	Business Operations
Hanaim International Llc		070319425	relabel(71056-112)

Establishment
Name	Address	ID/FEI	Business Operations
Goldeneye Permanent System Gmbh Germany		329178144	manufacture(71056-112)