GUARDANIA PAIN- capsaicin cream 
LHP Pharma, Inc

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Guardania Pain Cream

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:

Label

GUARDANIA PAIN 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71659-842
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71659-842-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/201709/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/10/201709/30/2019
Labeler - LHP Pharma, Inc (080702471)

Revised: 10/2023
 
LHP Pharma, Inc