X OUT DAILY BODY SCRUB

Main information

  • Trade name:
  • X OUT DAILY BODY 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:
  • X OUT DAILY BODY SCRUB- salicylic acid lotion
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Acne Treatment for the management of acne.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 11410-004-48, 11410-004-80
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

X OUT DAILY BODY SCRUB- salicylic acid lotion

Guthy-Renker 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.

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X Out Daily Body Scrub

Drug Facts

Active ingredient

Salicylic Acid 2%

Purpos e

Acne Treatment

Us e

for the management of acne.

Warnings

For external use only

When using this product

skin irritation and dryness are 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.

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

If irritation becomes severe.

Keep out of reach of children.

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

Directions

apply a small amount to dampened skin.

cover the entire affected area with a thin layer and rinse thoroughly 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.

Inactive ingredients

water, cocamidopropyl betaine, polyethylene, distearyl phthalic acid amide, cetyl alcohol, stearyl

alcohol, ammonium laureth sulfate, sodium chloride, camellia sinensia leaf extract, aloe vera leaf juice,

menthol, butylene gylcol, PEG-120 methyl glucose dioleate, sodium hydroxide, disodium EDTA,

butylparaben, ethylparaben, isobutylparaben, methylparaben, phenoxyethanol, propylparaben, fragrance.

®

Questions or comments?

Within US 1-800-950-4465

Dist. by: Guthy-Renker

LLC PO Box 14383 Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

X

OUT

DAILY

BODY SCRUB

From the Makers of Proactiv

salicylic acid acne treatment

8 FL. OZ. 240 mL

X OUT DAILY BODY SCRUB

salicylic acid lotion

®

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11410 -0 0 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC 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)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9 LI)

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

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

SO DIUM LAURETH-3 SULFATE (UNII: BPV39 0 UAP0 )

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

MENTHO L (UNII: L7T10 EIP3A)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

PEG-12 0 METHYL GLUCO SE DIO LEATE (UNII: YM0 K6 4F20 V)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

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

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

ETHYLPARABEN (UNII: 14255EXE39 )

ISO BUTYLPARABEN (UNII: 0 QQJ25X58 G)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:11410 -0 0 4-48

120 mL in 1 BOTTLE, PLASTIC

2

NDC:11410 -0 0 4-8 0

240 mL in 1 BOTTLE, PLASTIC

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

12/31/20 12

Labeler -

Guthy-Renker LLC (608315453)

Guthy-Renker LLC

Revised: 1/2013