SATOHAP PADS- dl-camphor, l-menthol, methyl salicylate patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Fuji Seal, Inc.

INN (International Name):

CAMPHOR - UNII:5TJD82A1ET)

Composition:

CAMPHOR (SYNTHETIC) 5 mg

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose dl-Camphor External analgesic l-Menthol External analgesic Methyl Salicylate External analgesic Uses temporary relieves minor aches and pains of muscles and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

SATOHAP PADS- DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE PATCH
FUJI SEAL, INC.
_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
dl-Camphor 0.5%
l-Menthol 0.4%
Methyl Salicylate 0.8%
Purpose
dl-Camphor External analgesic
l-Menthol External analgesic
Methyl Salicylate External analgesic
Uses temporary relieves minor aches and pains of muscles and joints
associated with
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains
Warnings
For external use only
Do not use
■ on wounds or on damaged skin
When using this product
■ avoid contact with the eyes
■ do not bandage tightly
Stop use and ask a doctor if
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again withn a few days
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
Directions
■ Strip off the polyethylene film and place adhesive pad over
affected area.
■ Change pad 1 or 2 times a day
■ Not for children under 4 years.
Inactive ingredients
aluminum hydroxide gel, carbomer, carmellose sodium, edetate disodium,
glycerin, malic acid,
methacrylic acid and n-butyl acrylate copolymer, partially hydrolyzed
polyvinyl alcohol, partially
neutralized polyacrylate, PEG 60 hydrogenated castor oil, sorbitol,
titanium dioxide, water.
SATOHAP PADS
dl-camphor, l-menthol, methyl salicylate patch
Fuji Seal, Inc.
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:718 9 5-0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -
UNII:5TJD8 2A1ET)
CAMPHOR (SYNTHETIC)
5 mg
LEVO MENTHO L (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)
LEVOMENTHOL
4 mg
METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METH