EVENING MOISTURIZER- salicylic acid cream 
SGII, 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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Evening Moisturizer

Active Ingredient

Salicylic Acid 1%

Purpose

Salicylic Acid 1%........Acne Treatment

Uses

For the treatment of acne

Warnings

For External Use Only

Keep Out Of Eyes

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

Clean the skin thoroughly before applying this product

• Cover the entire affected area with a thin layer 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

Inactive Ingredients

Sodium Hyaluronate, Panthenol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Arginine, Dimethicone, Ceteth-10 Phosphate, Dicetyl Phosphate, Hydrolyzed Caesalpinia Spinosa Gum, Phenoxyethanol, Cetyl Palmitate, Caprylyl Glycol, Sorbitan Palmitate, Propylene Glycol, Butylene Glycol, Caesalpinia Spinosa Gum, Ethylhexylglycerin, Hexylene Glycol, Bisabolol, Tetrasodium EDTA, Potassium Sorbate, Sodium Benzoate, Urea*, Glucosamine HCl, Sodium Metabisulfite, Citric Acid, Parfum/Fragrance. *synthetic

PDP

EVENING MOISTURIZER 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72644-635
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERETH-26 (UNII: NNE56F2N14)  
JOJOBA OIL (UNII: 724GKU717M)  
SHEA BUTTER (UNII: K49155WL9Y)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
GINGER (UNII: C5529G5JPQ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CUCUMBER JUICE (UNII: 61845009SP)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
CORALLINA OFFICINALIS (UNII: 4004498D06)  
ANACAMPTIS MORIO FLOWER (UNII: PT2C4RA48D)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ARGININE (UNII: 94ZLA3W45F)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
EDETATE SODIUM (UNII: MP1J8420LU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LEVOMENOL (UNII: 24WE03BX2T)  
UREA (UNII: 8W8T17847W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72644-635-0130 g in 1 BOTTLE; Type 0: Not a Combination Product09/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/16/2020
Labeler - SGII, INC. (070096792)
Establishment
NameAddressID/FEIBusiness Operations
220 LABORATORIES INC783247950manufacture(72644-635)

Revised: 9/2020
Document Id: af741928-c852-4c2a-e053-2995a90a7c1d
Set id: af741928-c851-4c2a-e053-2995a90a7c1d
Version: 1
Effective Time: 20200916
 
SGII, INC.