PORE RESCUE ACNE- 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

For the treatment of acne

Keep out of reach of children

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

Directions

Cleanse the skin thorooughly 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.

Warnings
For external use only

If swallowed , get medical help or contact poison control center right away.

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

Bioelements

Acne Clearing System

Pore Rescue Acne Gel

1% Salicylic Acid
Acne Treatment Gel

29 mL / 1 Fl. Oz.

PORE RESCUE ACNE
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49825-125
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49825-125-02	1 in 1 BOX	05/02/2012	06/14/2017
1	NDC:49825-125-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:49825-125-04	1 in 1 BOX	05/02/2012	06/14/2017
2	NDC:49825-125-03	59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	05/02/2012	06/14/2017

Labeler - Bioelements (174813923)

Registrant - Bioelements (174813923)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmetic Enterprise		017701475	manufacture(49825-125)

Revised: 6/2017

Document Id: 342d7e96-396b-47fb-a808-e3e39b024173

Set id: 55baf4f4-a137-42b7-b75c-92dc3ac894ec

Version: 6

Effective Time: 20170615

Bioelements