999 ITCH RELIEF- menthol ointment

999 ITCH RELIEF by

Drug Labeling and Warnings

999 ITCH RELIEF by is a Otc medication manufactured, distributed, or labeled by China Resources Sanjiu Medical & Pharmaceutical Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Menthol 1%

Camphor (synthetic) 1%

Dexamethasone Acetate 0.075%

Purpose

External Analgesic

External Analgesic

Anti-allergic

For the temporary relief of pain caused by itching and rashes, poison ivy, poison oak

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

Directions

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

Warnings

Keep out of reach of children.

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.

Other Information

Keep in a lightly closed container. Store at 8 to 30 degree centigrade (46-86 Fahrenheit) in a dry plac away from sunlight.

Inactive Ingredients

Hexadecanolactone

Ethylparaben

Glycerin

Glycertyl Monostearate

Drug Facts

INGREDIENTS AND APPEARANCE

999 ITCH RELIEF 
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12753-930
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	200 mg  in 20000 mg
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	200 mg  in 20000 mg
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	15 mg  in 20000 mg

Inactive Ingredients
Ingredient Name	Strength
HEXADECANOLACTONE (UNII: 64E2HO00C7)
Ethylparaben (UNII: 14255EXE39)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12753-930-19	20000 mg in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/03/2003

Labeler - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711)

Registrant - China Resources Sanjiu Medical & Pharmaceutical Co Ltd (544695711)

Establishment
Name	Address	ID/FEI	Business Operations
China Resources Sanjiu Medical & Pharmaceutical Co Ltd		544695711	manufacture(12753-930)