ELEMENT 47 FACE AND BODY ACNE TREATMENT- salicylic acid spray 
Worldceuticals, 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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Element 47 Face and Body Acne Treatment

Active Ingredient

Salicylic Acid (0.5%)

Purpose

Acne Treatment

Uses

• For the treatment of acne. • Penetrates pores to help control acne blemishes

Warnings

• For external use only.

When using this product

• Avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.

• Using other topical acne medications at the same time or immediately following use of this product may increase

dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep out of the reach of children.

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

Directions

• Cleanse the skin thoroughly before applying

• For chest and back, spray on affected areas one to three times daily. For face, apply with a cotton ball to entire face 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

Sensitivity 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.

Inactive Ingredients

• Aqua (Water), Propanediol, CoTcamidopropyl Betaine, Aloe

Barbadensis Leaf Juice, Colloidal Silver (preservative)*, Tocopheryl Acetate, Glycerin, Allantoin, Citrus

Grandis (Grapefruit) Fruit Extract, Lauryl Glucoside, Tetrasodium EDTA, PEG/PPG-4/12 Dimethicone,

Sodium Benzoate, Potassium Sorbate, Diazolidinyl Urea, Sodium Hydroxide (*Less than 1%)

Questions?

844-269-7296 www.Element47Skincare.com

Product Labeling

ELEMENT 47

FACE & BODY

ACNE TREATMENT

FACE & BODY

ACNE TREATMENT

FORMULATED FOR

SENSITIVE SKIN TYPES

8 FL. OZ. (240ML)

Bottle

Box

ELEMENT 47 FACE AND BODY ACNE TREATMENT 
salicylic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69753-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPANEDIOL (UNII: 5965N8W85T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
PUMMELO (UNII: ET1TN5W71X)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69753-002-001 in 1 CARTON04/10/201510/09/2017
1240 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/10/201510/09/2017
Labeler - Worldceuticals, LLC (079782424)
Establishment
NameAddressID/FEIBusiness Operations
Avadim Technologies, Inc.041443877manufacture(69753-002)

Revised: 10/2018
 
Worldceuticals, LLC