SLMD SALICYLIC ACID BODY WASH- salicylic acid liquid

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

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Active ingredient:
Salicylic Acid 2%
Available from:
Owen Biosciences Inc.
Administration route:
Topical
Prescription type:
OTC DRUG
Therapeutic indications:
for the management of acne When using this product: • 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. For the treatment of acne
Authorization status:
OTC monograph final
Authorization number:
59958-405-01, 59958-405-02

SLMD SALICYLIC ACID BODY WASH- salicylic acid liquid

Owen Biosciences Inc.

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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Active Ingredients

Salicylic Acid 2%

Us e

for the management of acne

Warnings

For external use only

When using this product:

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.

Keep out of reach of children.

If swallowed, get medical help or

contact a Poison Control Center

right away

Directions

use daily.

apply to wet hands and create a lather.

massage over wet skin concentrating on

areas prone to breakouts.

rinse thoroughly with warm water.

for best results use with SLMD Acne Body Spray.

Sensitivity Test for a New User: Apply

product sparingly to one or two small

affected areas during the first 3 days. If no

discomfort occurs, follow the directions

stated above.

Other information

Store in a cool, dry place.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Coco-Betaine, Glycerin, Aloe

Barbadensis Leaf Extract, Lauric Acid, Lactobacillus/Saccharomyces/Rice/Sucrose Ferment Filtrate,

Beta-glucan, Hydroxyphenyl Propamidobenzoic Acid, Lactic Acid, Panthenol, Allantion, Myristoyl

Tetrapeptide-13, Eucalyptus Globulus Leaf Oil, Retinyl Palmitate, Oligopeptide-8, Tocopheryl

Acetate, Simmodsia Chinensis (Jojoba) Seed Oil, Butylene Glycol, Disodium EDTA, Xanthan Gum,

Phenoxyethanol, Caprylyl Glycol, Pentylene Glycol.

Us e

For the treatment of acne

SA Body Wash.jpg

SA Body Wash.jpg

Owen Biosciences Inc.

SLMD SALICYLIC ACID BODY WASH

salicylic acid liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 9 58 -40 5

Route of Administration

To pic a l

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 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

58 .25 g in 10 0 g

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

8 .8 g in 10 0 g

DISO DIUM LAURETH SULFO SUCCINATE (UNII: D6 DH1DTN7E)

8 .5 g in 10 0 g

GLYCERIN (UNII: PDC6 A3C0 OX)

5 g in 10 0 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 9 58 -40 5-0 2

1 in 1 CARTON

0 8 /30 /20 19

1

NDC:59 9 58 -40 5-0 1

240 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333D

0 8 /30 /20 19

Labeler -

Owen Biosciences Inc. (790003045)

Registrant -

Owen Biosciences Inc. (790003045)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Owen Bio sciences Inc.

79 0 0 0 30 45

ma nufa c ture (59 9 58 -40 5)

Revised: 8/2019

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