CLEARASIL ULTRA RAPID ACTION SCRUB

Main information

  • Trade name:
  • CLEARASIL ULTRA RAPID ACTION SCRUB- salicylic acid lotion
  • Composition:
  • Salicylic Acid 2 g in 100 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLEARASIL ULTRA RAPID ACTION  SCRUB- salicylic acid lotion
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Acne medication for the treatment of acne

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 63824-416-65
  • Last update:
  • 02-06-2019

Summary of Product characteristics: dosage, interactions, side effects

CLEARASIL ULTRA RAPID ACTION SCRUB- salicylic acid lotion

RB Health (US) LLC

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.

----------

Clearas il

Ultra Rapid Action

Scrub

Drug Facts

Active ingredient

Salicylic acid 2%

Purpos e

Acne medication

Us e

for the treatment of acne

Warnings

For external use only

When using this product

avoid contact with the eyes. If the 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

wet face

dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area

cover the entire affected area with a thin layer and rinse thoroughly with warm water 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 occurs, reduce application to once a day or every other day

Other information

keep tightly closed

store in a cool, dry place

Inactive ingredients

®

water, polyethylene, PPG-15 stearyl ether, glycerin, stearyl alcohol, cetyl betaine, distearyldimonium

chloride, sodium lauryl sulfate, cetyl alcohol, alcohol, steareth-21, sodium chloride, behenyl alcohol,

synthetic wax, steareth-2, fragrance, Lavandula stoechas extract, Helichrysum italicum extract, Cistus

monspeliensis extract, xanthan gum, dimethyl palmitamine, lauryl alcohol, mica, isopropyl alcohol,

disodium EDTA, BHT, magnesium nitrate, methylchloroisothiazolinone, magnesium chloride,

methylisothiazolinone, sodium sulfate, ferric ferrocyanide, titanium dioxide, FD&C blue no. 1

Ques tions ?

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

You may also report side effects to this phone number

Distributed by: Reckitt Benckiser LLC

Parsippany, NJ 07054-0224

Made in France

PRINCIPAL DISPLAY PANEL - 150 mL Tube Label

Clearas il

ULTRA

Rapid Action

Face Scrub

Salicylic Acid 2% Acne Medication

MAXIMUM STRENGTH

12

HRS

Visibly

clearer skin

in as fast as

12 hours

5 FL OZ (150 mL)

®

CLEARASIL ULTRA RAPID ACTION SCRUB

salicylic acid lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 38 24-416

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Sa licylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)

Salicylic Acid

2 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

PPG-15 STEARYL ETHER (UNII: 1II18 XLS1L)

GLYCERIN (UNII: PDC6 A3C0 OX)

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

CETYL BETAINE (UNII: E9 45X0 8 YA9 )

RB Health (US) LLC

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

STEARETH-2 1 (UNII: 53J3F32P58 )

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

DO CO SANO L (UNII: 9 G1OE216 XY)

STEARETH-2 (UNII: V56 DFE46 J5)

LAVANDULA STO ECHAS FLO WERING TO P (UNII: 70 759 G2U6 A)

HELICHRYSUM ITALICUM FLO WER (UNII: P6 2Y550 X24)

XANTHAN GUM (UNII: TTV12P4NEE)

DIMETHYL PALMITAMINE (UNII: 5E4QI6 6 0 PW)

LAURYL ALCO HO L (UNII: 178 A9 6 NLP2)

MICA (UNII: V8 A1AW0 8 8 0 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MAGNESIUM NITRATE (UNII: 77CBG3UN78 )

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

MAGNESIUM CHLO RIDE (UNII: 0 2F3473H9 O)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

SO DIUM SULFATE (UNII: 0 YPR6 5R21J)

FERRIC FERRO CYANIDE (UNII: TLE29 4X33A)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 38 24-416 -6 5

150 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

12/0 1/20 13

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333D

12/0 1/20 13

Labeler -

RB Health (US) LLC (081049410)

Revised: 12/2018