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NDC 71659-0842-01 Guardania Pain 0.25 mg/mL Details

Guardania Pain 0.25 mg/mL

Guardania Pain is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by LHP Pharma, Inc. The primary component is CAPSAICIN.

MedlinePlus Drug Summary

Topical capsaicin is used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.

Related Packages: 71659-0842-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Capsaicin Topical

Product Information

NDC	71659-0842
Product ID	71659-842_566b7e0d-3e30-3298-e054-00144ff88e88
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	Guardania Pain
Proprietary Name Suffix	n/a
Non-Proprietary Name	CAPSAICIN
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.25
Active Ingredient Units	mg/mL
Substance Name	CAPSAICIN
Labeler Name	LHP Pharma, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71659-0842-01 (71659084201)

Pricing Information	N/A
NDC Package Code	71659-842-01
Billing NDC	71659084201
Package	118 mL in 1 BOTTLE (71659-842-01)
Marketing Start Date	2017-08-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 84db196d-daf9-46f6-810a-f1aa48bf763a Details

Drug Facts:

Active Ingredient:

Capsaicin 0.025%

Purpose

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings:

•For external use only.

•Avoid contact with eyes.

•If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

•If swallowed, consult physician.

•Do not apply to wounds or damaged skin.

•Do not bandage tightly.

If pregnant or breast feeding

contact physician prior to use.

Directions:

•Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.

•Children under two-years of age: consult a physician.

Additional Information:

Store at room temperature.

Other Ingredients:

Acrylates C10/30 Alkyl Acrylate Crosspolymer. Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-20, Triethanolamine

Package Labeling:

INGREDIENTS AND APPEARANCE

GUARDANIA PAIN

capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71659-842
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71659-842-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/10/2017

Labeler - LHP Pharma, Inc (080702471)

Revised: 8/2017

Document Id: 566b7e0d-3e30-3298-e054-00144ff88e88

Set id: 84db196d-daf9-46f6-810a-f1aa48bf763a

Version: 1

Effective Time: 20170810