Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream (Lidocaine, Menthol) Cream [Sato Pharmaceutical Co., Ltd.] -

SATOHAP LIDOCAINE 4% MENTHOL 1% PAIN RELIEVING CREAM (LIDOCAINE, MENTHOL) CREAM [SATO PHARMACEUTICAL CO., LTD.]
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NDC	49873-619-01
Set ID	2251e96b-d050-4ec2-a6b9-6659610885bf
Category	HUMAN OTC DRUG LABEL
Packager	Sato Pharmaceutical Co., Ltd.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/14/2018

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

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

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