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NDC 46581-0110-99 Salonpas 21.56; 41.73; 69.55 mg/1; mg/1; mg/1 Details

Salonpas 21.56; 41.73; 69.55 mg/1; mg/1; mg/1

Salonpas is a PERCUTANEOUS; TOPICAL; TRANSDERMAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Hisamitsu Pharmaceutical Co., Inc.. The primary component is CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE.

Product Information

NDC	46581-0110
Product ID	46581-110_e67a9c77-2cd4-4d0b-9d94-9ad02b026faf
Associated GPIs	90809903255935
GCN Sequence Number	080146
GCN Sequence Number Description	methyl salicylate/menth/camph ADH. PATCH 10-6-3.1 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	46845
HICL Sequence Number	002581
HICL Sequence Number Description	METHYL SALICYLATE/MENTHOL/CAMPHOR
Brand/Generic	Brand
Proprietary Name	Salonpas
Proprietary Name Suffix	n/a
Non-Proprietary Name	Camphor, Menthol, Methyl salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	PERCUTANEOUS; TOPICAL; TRANSDERMAL
Active Ingredient Strength	21.56; 41.73; 69.55
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Labeler Name	Hisamitsu Pharmaceutical Co., Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 46581-0110-99 (46581011099)

Pricing Information	N/A
NDC Package Code	46581-110-99
Billing NDC	46581011099
Package	2 PATCH in 1 POUCH (46581-110-99)
Marketing Start Date	2015-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL acdd5622-a9a7-4cc3-877e-57efea23303f Details

Active ingredients

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Purpose

Topical analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

arthritis
simple backache
strains
bruises
sprains

Warnings

For external use only

Allergy alert:

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

on wounds or damaged skin
with a heating pad
if you are allergic to any ingredients of this product

When using this product

use only as directed
avoid contact with the eyes, mucous membranes or rashes
do not bandage tightly

Stop use and ask a doctor if

rash, itching or excessive skin irritation develops
conditions worsen
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

clean and dry affected area
remove patch from film
apply to affected area not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Other information

avoid storing product in direct sunlight
protect product from excessive moisture

Inactive ingredients

mineral oil, perfume, polyisobutylene, styrene-isoprene-styrene block copolymer, synthetic aluminum silicate, terpene resin, titanium dioxide

Questions or comments?

Toll free 1-800-826-8861 www.salonpas.us

Principal Display Panel

OTC topical analgesics in patch category*

WORLD'S BRAND NO.1

Hisamitsu NDC#46581-110-60

for temporary relief of minor aches and pains

STIFF NECK

SORE SHOULDER

BACKACHE

JOINT PAIN

Salonpas

Pain Relieving Patch

APPLY FOR 8 HOURS

60 PATCHES

2.83" X 1.81" (7.2cm X 4.6cm)

MADE IN JAPAN

Principal Display Panel

CUT OPEN HERE

Hisamitsu NDC#46581-110-99

Stiff Neck Sore Shoulder Backache Joint Pain

Salonpas

Pain Relieving Patch

2 PATCHES

2.83" X 1.81" (7.2cm X 4.6cm)

SAMPLE ONLY / NOT FOR RE-SALE

INGREDIENTS AND APPEARANCE

SALONPAS

camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46581-110
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	21.56 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	41.73 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	69.55 mg

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:46581-110-60	3 in 1 BOX	06/01/2015
1		20 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:46581-110-20	1 in 1 BOX	12/01/2015
2		20 in 1 POUCH; Type 0: Not a Combination Product
3	NDC:46581-110-99	2 in 1 POUCH; Type 0: Not a Combination Product	07/01/2015
4	NDC:46581-110-14	7 in 1 BOX	08/01/2016
4		20 in 1 POUCH; 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	06/01/2015

Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)

Revised: 4/2020

Document Id: e67a9c77-2cd4-4d0b-9d94-9ad02b026faf

Set id: acdd5622-a9a7-4cc3-877e-57efea23303f

Version: 8

Effective Time: 20200406

Search by Drug Name or NDC

NDC 46581-0110-99 Salonpas 21.56; 41.73; 69.55 mg/1; mg/1; mg/1 Details

Salonpas 21.56; 41.73; 69.55 mg/1; mg/1; mg/1

Product Information

Package

Package Images

NDC 46581-0110-99 (46581011099)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL acdd5622-a9a7-4cc3-877e-57efea23303f Details

Active ingredients

Purpose

Uses

Warnings

Allergy alert:

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?

Principal Display Panel

Principal Display Panel

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