ROSEMARY AND SALICYLIC ACID ACNE CLEARING MOISTURIZER- salicylic acid cream 
Naturopathica Holistic Health

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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Rosemary and Salicylic Acid Acne Clearing Moisturizer

DRUG FACTS

Active Ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Use

For treatment of acne

Warning

For external use only

Ask a doctor or pharmacist before use if you are using other topical acne products at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Stop Use and Ask a Doctor if redness or irritation occurs. Avoid contact with eyes.

When using this product, avoid contact with eyes. If contact occurs, flush thoroughly with water. If your skin will be exposed to the sun after use, apply a sunscreen with an SPF of 30 or greater.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Questions or Comments?

call toll free 646-979-3997

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Glyceryl Stearate, Coconut Alkanes, Cetyl Alcohol, Glycerin, Stearic Acid, Glyceryl Stearate Citrate, Stearyl Alcohol, 1,2-Hexanediol, Xantham Gum, Cydonia Oblonga Leaf Extract, Citric Acid, Caprylyl Glycol, Maltodextrin, Bixa Orellana Seed Extract, Citrus Limon (Lemon) Peel Oil, Tocopherol, Spiraea Ulmaria (Meadowsweet) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Citrus Medica Limonum (Lemon) Peel Extract, Sodium Hyaluronate

Distributed by:
Naturopathica Holistic Health
New York, NY 10001.

PRINCIPAL DISPLAY PANEL - 50 ML Jar Carton

NATUROPATHICA®
FOR DEEPER BEAUTY

ROSEMARY &
SALICYLIC ACID

ACNE CLEARING
MOISTURIZER

1.7 FL OZ / 50 ML

PRINCIPAL DISPLAY PANEL - 50 ML Jar Carton
ROSEMARY AND SALICYLIC ACID ACNE CLEARING MOISTURIZER 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64657-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CYDONIA OBLONGA LEAF (UNII: 2184487NM7)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
BIXA ORELLANA SEED (UNII: O87354RZ5A)  
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
SPEARMINT OIL (UNII: C3M81465G5)  
ROSEMARY (UNII: IJ67X351P9)  
LEMON PEEL (UNII: 72O054U628)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64657-004-041 in 1 CARTON10/25/2021
150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/25/2021
Labeler - Naturopathica Holistic Health (104302175)

Revised: 12/2021
Document Id: 26d0fc93-9426-4f2f-83a8-68a29e84f439
Set id: 051a8989-f1ad-4899-a8a3-6df1d2fbf684
Version: 1
Effective Time: 20211201
 
Naturopathica Holistic Health