BDR RE-MOVE PH PURE HARMONY CLEANSER- salicylic acid liquid

bdr Re-move PH pure harmony cleanser by

Drug Labeling and Warnings

bdr Re-move PH pure harmony cleanser by is a Otc medication manufactured, distributed, or labeled by Goldeneye Permanent System Gmbh Germany. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Salicylic Acid (0.4%)

Purpose

Acne treatment

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

Directions

Shake well before use. Gently massage 2-3 pumps of Re-move PH Pure Harmony. Rinse thoroughly with water. Recommended for twice daily use, morning and evening.

Uses

For the treatment of acne. Helps to promote clear and refresh skin.

Inactive Ingredients

AQUA /WATER, CETEARYL ISONONANOATE, GLYCERIN, PANTHENOL, ETHYLHEXYL STEARATE, OCTYLDODECANOL, ALCOHOL, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER, SUCROSE STEARATE, PHENOXYETHANOL, ALLANTOIN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM HYDROXIDE, SODIUM SALICYLATE, PLANTAGO LANCEOLATA LEAF EXTRACT, XANTHAN GUM, PARFUM /FRAGRANCE, BENZOIC ACID, DEHYDROACETIC ACID, Cl 77820 (SILVER), MAHONIA AQUIFOLIUM ROOT EXTRACT, BOSWELLIA SERRATA RESIN EXTRACT, POTASSIUM SORBATE, SODIUM BENZOATE, SORBIC ACID, Cl 75810 (Chloroohvllin - Coooer comolex, Sodium coooer Chloroohvllin)

bdr Re-move PH pure harmony cleanser

INGREDIENTS AND APPEARANCE

BDR RE-MOVE PH PURE HARMONY CLEANSER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71056-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
OCTYLDODECANOL (UNII: 461N1O614Y)
ALCOHOL (UNII: 3K9958V90M)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
SUCROSE STEARATE (UNII: 274KW0O50M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71056-100-02	1 in 1 PACKAGE	10/24/2016
1	NDC: 71056-100-01	100 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
OTC monograph final	part333D	10/24/2016

Labeler - Hanaim International Llc (070319425)

Registrant - Hanaim International Llc (070319425)

Establishment
Name	Address	ID/FEI	Business Operations
Hanaim International Llc		070319425	relabel(71056-100)

Establishment
Name	Address	ID/FEI	Business Operations
Goldeneye Permanent System Gmbh Germany		329178144	manufacture(71056-100)