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NDC 45802-0174-53 Muscle Rub 10; 15 g/100g; g/100g Details

Muscle Rub 10; 15 g/100g; g/100g

Muscle Rub is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.

Product Information

NDC	45802-0174
Product ID	45802-174_04ef342d-042e-42c9-a400-0ad2549a3e72
Associated GPIs	90809902603700
GCN Sequence Number	061801
GCN Sequence Number Description	methyl salicylate/menthol CREAM (G) 15%-10% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	97586
HICL Sequence Number	002583
HICL Sequence Number Description	METHYL SALICYLATE/MENTHOL
Brand/Generic	Brand
Proprietary Name	Muscle Rub
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol, Methyl salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10; 15
Active Ingredient Units	g/100g; g/100g
Substance Name	MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Labeler Name	Padagis Israel Pharmaceuticals Ltd
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 45802-0174-53 (45802017453)

Pricing Information
NDC Package Code	45802-174-53
Billing NDC	45802017453
Package	1 TUBE in 1 CARTON (45802-174-53) / 85 g in 1 TUBE
Marketing Start Date	2011-03-03
NDC Exclude Flag	N
Price Per Unit	0.03185
Pricing Unit	GM
Effective Date	2023-11-22
NDC Description	MUSCLE RUB 15%-10% CREAM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL e617d01f-b366-48c4-944e-1097e319a11c Details

Active ingredients

Menthol 10%

Methyl salicylate 15%

Purpose

Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with

•: simple backache
•: arthritis
•: strains
•: bruises
•: sprains

Warnings

For external use only

Do not use

•: other than as directed
•: on children under 12 years of age
•: with a heating pad (may blister skin)

When using this product

•: avoid contact with the eyes or mucous membranes
•: do not apply to wounds or damaged skin
•: do not bandage tightly

Stop use and ask a doctor if

•: skin redness or excessive irritation of the skin develops
•: condition worsens or symptoms persist for more than 7 days
•: symptoms clear up and occur again within a few days

Keep out of reach of children

to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

•: adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
•: children under 12 years of age: consult a physician

Other information

•: store at 20°-25°C (68°-77°F)
•: Lot No. & Exp. Date, see crimp of tube and see box

Inactive ingredients

citric acid, glyceryl monostearate, lanolin, methylparaben, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions or comments?

1-800-719-9260

Principal Display Panel

Deep Penetrating Pain Relief

Fast Relief from Minor Arthritis, Backache, Muscle & Joint Pain

Compare to Bengay® active ingredients

Muscle Rub

Greaseless

Pain Relieving Cream

NET WT 3 OZ (85 g)

INGREDIENTS AND APPEARANCE

MUSCLE RUB

menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-174
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 g in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45802-174-53	1 in 1 CARTON	03/03/2011
1		85 g in 1 TUBE; 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	03/03/2011

Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021

Document Id: 04ef342d-042e-42c9-a400-0ad2549a3e72

Set id: e617d01f-b366-48c4-944e-1097e319a11c

Version: 4

Effective Time: 20211110