Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving (Lidocaine Hydrochloride) Lotion [Sato Pharmaceutical Co., Ltd.] -

SATOHAP LIDOCAINE HYDROCHLORIDE 4 PERCENT PAIN RELIEVING (LIDOCAINE HYDROCHLORIDE) LOTION [SATO PHARMACEUTICAL CO., LTD.]
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NDC	49873-618-01
Set ID	f7faddb2-5153-4fdd-a5ef-778182cef460
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 hydrochloride 4%
PURPOSE

Purpose

Lidocaine hydrochloride - Topical analgesic
INDICATIONS & USAGE

Uses

For temporary relief of pain and itching
WARNINGS
Warnings

For external use only

Flammable: Keep away from fire and flame

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
- avoid storing in direct sunlight
- store with lid tightly closed
INACTIVE INGREDIENT

Inactive ingredients alcohol, propylene glycol, sodium hydroxide, water
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SATOHAP LIDOCAINE HYDROCHLORIDE 4 PERCENT PAIN RELIEVING
lidocaine hydrochloride lotion

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49873-618-01	1 in 1 CARTON	11/19/2018
1		80 mL in 1 BOTTLE, WITH APPLICATOR; 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	11/19/2018

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

Name	Address	ID/FEI	Business Operations
Establishment
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-618) , pack(49873-618) , label(49873-618)

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