ACNE WASH- salicylic acid solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Kamins Dermatologics
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Salicylic acid 2% medicated solution for acne A gentle effective cleanser with lactic, glycolic and salicylic acids to help control acne breakouts without overdrying the skin A gentle skin cleanser that effectively helps to control acne breakouts. Contains moisturizing Bio-MapleTM compound, which prevents skin from overdrying.
Authorization status:
OTC monograph final
Authorization number:
63550-119-17

ACNE WASH- salicylic acid solution

Kamins Dermatologics

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.

----------

Dos age

apply to wet face, gently massage with fingertips and rinse thoroughly. Use once daily, increasing up to

2-3 times daily.

Indications

Salicylic acid 2%

medicated solution for acne

A gentle effective cleanser with lactic,

glycolic and salicylic acids to help

control acne breakouts without

overdrying the skin

Keep out of reach of children

Keep out of reach of children. If swallowed seek medical assisstance or contact a Poison Control

Center immediately.

Purpos e

A gentle skin cleanser that effectively helps to control acne breakouts. Contains moisturizing Bio-

MapleTM compound, which prevents skin from overdrying.

Warnings

For external only:

When using this product

■ avoid contact with eyes; if contact occurs,

rinse thoroughly with water.

■ If excessive skin irritation develops or

increases, discontinue use; if irritation

persists, consult a health care

professional.

■ it is recommended that prior to exposure

to the sun, users cover with sunscreen

areas to which AHAs have been applied

(i.e. glycolic acid, lactic acid) and for one

week afterwards.

■ using other topical acne products at the

same time or right after use of this

product may increase dryness or irritation

of the skin. If this occurs, only one drug

should be used unless directed by a

health care professional.

Active ingredient

Active ingredient: Salicylic Acid

Inactive ingredients

Inactive ingredients:

aqua/water/eau, lauryl glucoside, PEG-120 methyl glucosedioleate, acer saccharum (maple isolate

/isolat d’érable), glycerin, PEG-7 glycerylcocoate, glycolic acid, lactic acid, sodiumhydroxide,

panthenol, allantoin, menthapiperita (peppermint) oil.

ACNE WASH

salicylic acid solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 3550 -119

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

20 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

LAURYL GLUCO SIDE (UNII: 76 LN7P7UCU)

20 0 mg in 1 mL

PANTHENO L (UNII: WV9 CM0 O6 7Z)

1.3 mg in 1 mL

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

9 .4 mg in 1 mL

ALLANTO IN (UNII: 344S277G0 Z)

1 mg in 1 mL

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

1 mg in 1 mL

ACER SACCHARUM BARK/SAP (UNII: Z120 VL0 KAC)

30 mg in 1 mL

GLYCERIN (UNII: PDC6 A3C0 OX)

30 mg in 1 mL

PEG-7 GLYCERYL CO CO ATE (UNII: VNX7251543)

30 mg in 1 mL

GLYCO LIC ACID (UNII: 0 WT12SX38 S)

7.5 mg in 1 mL

LACTIC ACID (UNII: 33X0 4XA5AT)

10 mg in 1 mL

WATER (UNII: 0 59 QF0 KO0 R)

58 7.3 mg in 1 mL

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

50 mg in 1 mL

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 3550 -119 -17

18 0 mL in 1 BOTTLE; Type 6 : Drug/Bio lo gic Co mbinatio n

10 /0 1/20 0 4

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Kamins Dermatologics

OTC mo no graph final

pa rt358 B

10 /0 1/20 0 4

Labeler -

Kamins Dermatologics (254050784)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Odan Labo rato ries

20 8 58 56 0 4

ma nufa c ture (6 3550 -119 )

Revised: 12/2019

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