SATOHAP LIDOCAINE 4% MENTHOL 1% PAIN RELIEVING CREAM- lidocaine, menthol cream

Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream by

Drug Labeling and Warnings

Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Lidocaine 4%

Menthol 1%

PURPOSE

Purpose

Lidocaine  Topical analgesic

Menthol   Topical analgesic

INDICATIONS & USAGE

Uses

For temporary relief of pain

WARNINGS

Warnings

For external use only

Do not use in large quantities, particularly over raw surfaces or blistered areas

When using this product avoid contact with the eyes

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• a rash or irritation develops

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

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times dailly
• children under 12 years of age: do not use, ask a doctor

OTHER SAFETY INFORMATION

Other information

• protect product from excessive moisture
• avoid storing in direct sunlight
• store with lid tightly closed

INACTIVE INGREDIENT

Inactive ingredients benzyl alcohol, butylene glycol, carbomer homopolymer (type C), isopropyl myristate, polyoxyl 40 hydrogenated castor oil, sodium hydroxide, water

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SATOHAP LIDOCAINE 4% MENTHOL 1% PAIN RELIEVING CREAM 
lidocaine, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-619
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-619-01	1 in 1 CARTON	11/14/2018
1		100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/14/2018

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	pack(49873-619) , label(49873-619) , manufacture(49873-619)