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NDC 50804-0077-01 GOOD SENSE ULTRA STRENGTH MUSCLE RUB 40; 100; 300 mg/g; mg/g; mg/g Details

GOOD SENSE ULTRA STRENGTH MUSCLE RUB 40; 100; 300 mg/g; mg/g; mg/g

GOOD SENSE ULTRA STRENGTH MUSCLE RUB is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by GOOD SENSE. The primary component is CAMPHOR, (-)-; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.

Product Information

NDC	50804-0077
Product ID	50804-077_a79b94e0-009a-4561-abd6-7d378e022dd9
Associated GPIs	90809903253740
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	GOOD SENSE ULTRA STRENGTH MUSCLE RUB
Proprietary Name Suffix	n/a
Non-Proprietary Name	CAMPHOR, (-)-, MENTHOL, UNSPECIFIED FORM, and METHYL SALICYLATE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40; 100; 300
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	CAMPHOR, (-)-; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Labeler Name	GOOD SENSE
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 50804-0077-01 (50804007701)

Pricing Information	N/A
NDC Package Code	50804-077-01
Billing NDC	50804007701
Package	1 TUBE in 1 CARTON (50804-077-01) / 113 g in 1 TUBE
Marketing Start Date	2018-12-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ed9297f7-7f01-4ef1-81af-d9c90650672b Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Camphor 4%	Topical analgesic
Menthol 10%	Topical analgesic
Methyl salicylate 30%	Topical analgesic

Use

Temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only.

Avoid contact with eyes and mucus membranes.

Not for prolonged use.

Do not use

than otherwise directed
on wounds or damaged skin
a bandage tightly

Stop use and ask a physician if

rash or excessive irritation of the skin develops
condition worsens or symptoms persist for more than 7 days
condition clears up and occurs 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: 800-222-1222.

Directions

Adults and children 12 years of age and older:

apply to affected area 3 to 4 times daily

Children under 12 years old:

consult a physician

Other information

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

carbomer, cetyl alcohol, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, potassium cetyl phosphate, propylparaben, purified water, stearic acid, stearyl alcohol, triethanolamine

Questions or comments?

1-866-323-0107

SPL UNCLASSIFIED SECTION

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

NDC 50804-077-01

GOODSENSE®

Ultra Strength

Muscle

Rub

For Fast Acting Relief from

Muscle Ache & Arthritis Pain!

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Greaseless,

Stainless & Long

Lasting Cream

Compare to active ingredients of

Bengay® Ultra*

NET WT 4 oz (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

INGREDIENTS AND APPEARANCE

GOOD SENSE ULTRA STRENGTH MUSCLE RUB

camphor, (-)-, menthol, unspecified form, and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-077
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275)	CAMPHOR, (-)-	40 mg in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	300 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50804-077-01	1 in 1 CARTON	12/19/2018
1		113 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	12/19/2018

Labeler - GOOD SENSE (076059836)

Name	Address	ID/FEI	Business Operations
Establishment
NATUREPLEX LLC		062808196	MANUFACTURE(50804-077)

Revised: 6/2021

Document Id: a79b94e0-009a-4561-abd6-7d378e022dd9

Set id: ed9297f7-7f01-4ef1-81af-d9c90650672b

Version: 2

Effective Time: 20210616

Search by Drug Name or NDC

NDC 50804-0077-01 GOOD SENSE ULTRA STRENGTH MUSCLE RUB 40; 100; 300 mg/g; mg/g; mg/g Details

GOOD SENSE ULTRA STRENGTH MUSCLE RUB 40; 100; 300 mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 50804-0077-01 (50804007701)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ed9297f7-7f01-4ef1-81af-d9c90650672b Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Use

Warnings

Do not use

Stop use and ask a physician if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

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