999 ITCH RELIEVING- hydrocortisone ointment 
Guangdong CR. Shunfeng 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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999 ITCH RELIEVING OINTMENT

ACTIVE INGREDIENTS

Hydrocortisone 1.0%

Purpose

Anti-Itch

Use

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: cosmetics, insect bites, psoriasis, eczema, seborrheic dermatitis.

Warnings

For external use only. Avoid contact with the eyes. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and seek medical advice if

Condition worsens. Symptoms persist for more than 7 days. Symptoms clear up and occur again within a few days. Excessive irritation of the skin develops.

Directions

Adult and children 2 years of age and older. Apply liberally to affected area not more than 5 times daily and 5-8 times per day for some severe cases or follow doctor's instruction.

Pregnant and children under 2 years of age. Do not use, consult a doctor.

Keep out of reach of children.

Other Information

Keep in a tightly closed container. Store at 8 to 30 ℃ (46-86℉) in a dry place away from sunlight.

You may report serious side effects to: 1452 W. Holt Ave, Pomona, CA 91768

Inactive Ingredients

Glyceryl Monostearate

Glyceryl Distearate

Glycerin

Stearic Acid

Mineral Oil

Petrolatum

Paraffin

Ceresin

Beta Carotene

Ethylparaben

Sodium Lauryl Sulfate

Drug Facts

carton

Manufactured By Guangdong CR. Shunfeng Pharmaceutical Co.; Ltd.

Jinjuzu, Dalinag Street, Shunde District, Foshan, Guangdong, China 528300

Distributed by Master Herbs Inc.

1452 W. Holt Ave, Pomona, CA 91768

(866)487-8373

999 ITCH RELIEVING 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69436-930
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CERESIN (UNII: Q1LS2UJO3A)  
BETA CAROTENE (UNII: 01YAE03M7J)  
ETHYLPARABEN (UNII: 14255EXE39)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69436-930-201 in 1 BOX
120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/20/1989
Labeler - Guangdong CR. Shunfeng Pharmaceutical Co Ltd (654033877)
Registrant - Guangdong CR. Shunfeng Pharmaceutical Co Ltd (654033877)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong CR. Shunfeng Pharmaceutical Co Ltd654033877manufacture(69436-930)

Revised: 2/2015
Document Id: e99d3820-7f23-4d98-a41d-dcb141f80090
Set id: 190a2618-f33d-4fe6-97e2-d145e88fdc2c
Version: 3102
Effective Time: 20150211
 
Guangdong CR. Shunfeng Pharmaceutical Co Ltd