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

Lidocaine 4%

Menthol 1%

Purpose

Lidocaine  Topical analgesic

Menthol   Topical analgesic

Uses

For temporary relief of pain

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.

Directions

Other information

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

PDP

Carton

SATOHAP LIDOCAINE 4% MENTHOL 1% PAIN RELIEVING CREAM 
lidocaine, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-619
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-619-011 in 1 CARTON11/14/2018
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/14/2018
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133pack(49873-619) , label(49873-619) , manufacture(49873-619)

Revised: 11/2018
Document Id: 1b11b27c-c9f7-4954-a035-64839639f007
Set id: 2251e96b-d050-4ec2-a6b9-6659610885bf
Version: 1
Effective Time: 20181114
 
Sato Pharmaceutical Co., Ltd.