Sound Body by Big Lots Stores, Inc.

Sound Body by

Drug Labeling and Warnings

Sound Body by is a Otc medication manufactured, distributed, or labeled by Big Lots Stores, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOUND BODY- salicylic acid cream 
Big Lots Stores, 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 ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses   -for the treatment of acne   -clears blackheads

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 acen medication at a time.

Avoid contact with eyes. If contact occurs, flush thoroughly

with water.

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Directions  -wet face  -gently massage over face for 20-30

seconds, avoiding eye area  -rinse thoroughly and pat dry

-recommended for daily use.

Inactive ingredients  water, cetyl alcohol, PPG-15 stearyl ether,

hydrogenated castor oil, microcrystalline wax, potassium

cetyl phosphate, steareth-21, polysorbate 60, carnauba (copernicia cerifera)

wax, xantham gum, fragrance, menthyl lactate, blue 1

SOUND BODY 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-529
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)
CETYL ALCOHOL (UNII: 936JST6JCN)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
STEARETH-21 (UNII: 53J3F32P58)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CARNAUBA WAX (UNII: R12CBM0EIZ)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50594-529-16	141 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2016	12/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/01/2016	12/31/2016

Labeler - Big Lots Stores, Inc. (017885351)

Revised: 1/2020

Document Id: 9bc9ead8-61fe-9d08-e053-2995a90aa0d6

34390-5

Set id: 14abef52-b30f-4554-a7ec-95983ae0193c

Version: 2

Effective Time: 20200110

 

Big Lots Stores, Inc.