PORE RESCUE ACNE BIOLEMENTS- salicylic acid gel 
Bioelements

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pore Rescue Acne Gel

Active ingredient       Purpose

Salicylic Acid 1%       Acne Treatment

Use

Fo the treatment of acne

keep out of reach of children.

When using this product: skin irritation and dryness is more likely if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Warnings

For external use only

If swallowed, get medical help or contact a posion control center right away

Direction Cleanse the skin thoroughly before applying this product. Cover the affected area with a thin layer daily. If bothersome dryness or peeling occurs, reduce application to every other day.

Water (Aqua, Eau), Isopropyl Alcohol, Propylene Glycol, Dehydroxanthan Gum, Salix Alba (Willow) Bark Extract, Lavandula Angustifolia (Lavender) Oil, Sodium Citrate, Lauric Acid, Potassium Sorbate, Disodium EDTA.

label

bottle

box

Bioelements

Acne Clearing System

Pore Rescue Acne Gel

1% salicylic acid acne treatment gel

penetrates pores to control acne

29 mL./ 1 Fl. Oz.

PORE RESCUE ACNE  BIOLEMENTS
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
LAURIC ACID (UNII: 1160N9NU9U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49825-127-021 in 1 BOX06/13/201301/01/2016
1NDC:49825-127-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49825-127-041 in 1 BOX06/13/201301/01/2016
2NDC:49825-127-0359 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/13/201301/01/2016
Labeler - Bioelements (174813923)
Registrant - Bioelements (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprise017701475manufacture(49825-127)

Revised: 4/2016
Document Id: b608a6a4-5ef0-422c-94a4-1eb23245234a
Set id: 9f6ded42-6c77-4d96-b73e-15209c67dce2
Version: 3
Effective Time: 20160428
 
Bioelements