CLEARASIL RAPID RESCUE SPOT TREATMENT- salicylic acid gel

Clearasil Rapid Rescue Spot Treatment by

Drug Labeling and Warnings

Clearasil Rapid Rescue Spot Treatment by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic acid 2%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Flammable keep away from extreme heat or open flame

When using this product

• avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water.
• skin irritation and dryness is more 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.
• limit use to the face and neck

Stop use and ask a doctor if skin or eye irritation develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

• keep outer box for full product information
• store in a cool dry place

Inactive ingredients

Water, Alcohol Denat., Polysorbate 20, Sorbitol, Hydroxyethylcellulose, Glycerin, Sodium Hydroxide, Fragrance, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Menthol, Disodium EDTA

Questions?

1-866-25-CLEAR (1-866-252-5327).

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by:
RB Health (US)
Parsippany, NJ
07054-0224

Made in Brazil

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Clearasil®

RAPID RESCUE
SPOT TREATMENT
GEL

Salicyclic Acid Acne Medication

Maximum Strength

VISIBLE
RESULTS
AS FAST AS
4 HOURS

INVISIBLE

STARTS TO WORK
INSTANTLY

INGREDIENTS AND APPEARANCE

CLEARASIL RAPID RESCUE SPOT TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-434
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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sorbitol (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
Sodium Hydroxide (UNII: 55X04QC32I)
Helichrysum Italicum Flower (UNII: P62Y550X24)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-434-01	1 in 1 CARTON	12/06/2017
1		28 g in 1 TUBE; 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	12/06/2017

Labeler - RB Health (US) LLC (081049410)