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NDC 63629-8310-01 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 Bryant Ranch Prepack. The primary component is CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.

Product Information

NDC	63629-8310
Product ID	63629-8310_f9596efc-da7c-4653-a751-5ad56036f4a9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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, UNSPECIFIED FORM; METHYL SALICYLATE
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63629-8310-01 (63629831001)

Pricing Information	N/A
NDC Package Code	63629-8310-1
Billing NDC	63629831001
Package	20 PATCH in 1 POUCH (63629-8310-1)
Marketing Start Date	2022-02-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e5a244fc-8c20-455e-a7cd-d1bc0c6e50c7 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

HOW SUPPLIED

NDC: 63629-8310-1: 20 Patchs in a POUCH

PRINCIPAL DISPLAY PANEL

Salonpas Pain Relief Blister patch

INGREDIENTS AND APPEARANCE

SALONPAS

camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-8310(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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	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	Marketing End Date
Packaging
1	NDC:63629-8310-1	20 in 1 POUCH; Type 0: Not a Combination Product	02/22/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/01/2015

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-8310) , RELABEL(63629-8310)

Revised: 2/2022

Document Id: f9596efc-da7c-4653-a751-5ad56036f4a9

Set id: e5a244fc-8c20-455e-a7cd-d1bc0c6e50c7

Version: 3

Effective Time: 20220222