ROSAACNE RELIEF- sulfur, salicylic acid ointment 
Kunming Zhongzhou Pharmaceutical Co, Ltd

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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Kunming Zhongzhou Pharmaceutical Co, Ltd

Active Ingredients

Sulfur         7.1%
Salicylic Acid           3%

Purpose

Acne Treatment

Uses

For the treatment of acne

Warning

For external use only.

When using this product

1. Some patients may have aggravated symptoms within 10 days of use; but may start to improve after 2 weeks.
2. The product is recommended to use continuously without interruption.
3. Skin irritation and dryness are likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne product at a time.
4. Pregnant or breast-feeding women and children use with caution.
5. Avoid contact with eyes.
6. If dryness, slight burn feeling or skin peeling occurs, reduce application and use one time a day or every other day.

Do not use

If you are allergic to any ingredient(s) of the product.

Keep out of reach of children.

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

Directions

Cleanse the skin thoroughly before applying this product twice a day.

Storage

Keep in a dry, cool place away from direct sunlight.

Manufactured by:
Kunming Zhongzhou Pharmaceutical Co. Ltd
No. 16 Jingdong Road, Kunming, China
Made in China

Distributed exclusively by:
AL Lauren Corp. Temple City, CA 91780 USA

Inactive Ingredients

Zinc Oxide, Boric Acid, Menthol, Dimethicone, Petrolatum, Stearic Acid, Octadecanol (Mixture of Isomers), Glycerin,
Glyceryl Monostearate, Water

Drug Facts

image description

ROSAACNE RELIEF 
sulfur, salicylic acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72317-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR7.1 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Zinc Oxide (UNII: SOI2LOH54Z)  
Boric Acid (UNII: R57ZHV85D4)  
Menthol (UNII: L7T10EIP3A)  
Dimethicone (UNII: 92RU3N3Y1O)  
Petrolatum (UNII: 4T6H12BN9U)  
Stearic Acid (UNII: 4ELV7Z65AP)  
OCTADECANOL (MIXTURE OF ISOMERS) (UNII: C6BPY2QY39)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72317-001-011 in 1 BOX07/18/2018
120 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/18/2018
Labeler - Kunming Zhongzhou Pharmaceutical Co, Ltd (529561942)

Revised: 7/2018
Document Id: e9dd15ee-22bd-4bcd-b5ff-20cb9bf8a4af
Set id: 2fda4df9-9449-4ded-b903-b93dd8efb19b
Version: 32463
Effective Time: 20180730
 
Kunming Zhongzhou Pharmaceutical Co, Ltd