GUARDANIA PAIN- capsaicin cream

Guardania Pain by

Drug Labeling and Warnings

Guardania Pain by is a Otc medication manufactured, distributed, or labeled by LHP Pharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - LHP Pharma, Inc (080702471)