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 gel 
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

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  -cleanse twice daily  -gently massage onto wet

face, add water amd work into a lather  -rinse thoroughly

Inactive ingredients   sodium C14-16 olefin sulfonate,

water, cocamidopropyl betaine, propylene glycol, fragrance,

PEG-8- sorbitan laurate, C12-15 alkyl lactate, cocamidopropyl

PG-dimonium chloride phosphate, benzalkonium chloride,

chamomilla recutita (matricaria) flower extract, disodium EDTA,

aloe barbadensis leaf juice, red 40, yellow 5.

SOUND BODY 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-530
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
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CHAMOMILE (UNII: FGL3685T2X)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50594-530-16	177 g in 1 BOTTLE, PUMP; 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: 9bc9fe54-aba1-d5d8-e053-2a95a90a3720

34390-5

Set id: bd0b3a9d-6d83-44bb-8306-3a3b29d691a3

Version: 2

Effective Time: 20200110