CAPSAICIN CREAM- capsaicin cream

Capsaicin Cream by

Drug Labeling and Warnings

Capsaicin Cream by is a Otc medication manufactured, distributed, or labeled by A2A Integrated Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Capsaicin 0.1%

PURPOSE

External Analgesic

INDICATIONS & USAGE

Uses

Temporarily relieves minor aches and pains of muscles and joints due to

simple backache
arthritis
strains
sprains

WARNINGS

Warnings

For external use only

Read all warnings and directions before use. Test first on small area of skin.

DO NOT USE

Do not use:

on wounds or damaged skin
if you are allergic to capsaicin or chili peppers

WHEN USING

When using this product:

you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. with regular use, this sensation generally disappears after several days
avoid contact with the eyes, lips, nose, and mucous membranes
do not tightly wrap or bandage the treated area
do not apply heat to the treated area immediately before or after use.

ASK DOCTOR

Ask Doctor

Stop use and ask a doctor if:

condition worsens or does not improve after regular use
severe burning persists or blistering occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Adults and children 18 years of age and older:

apply a thin film of cream to affected area and gently tub in until fully absorbed
unless treating hands, wash hands thoroughly with soap and water immediately after application
for best results apply 3 to 4 times daily.

Children under 18 years: ask a doctor

STORAGE AND HANDLING

Other Information: Store at room temperature 15°- 30°C (59° - 86°F)

INACTIVE INGREDIENT

aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum.

QUESTIONS

Questions or comments?

Call (800) 380-6709

Distributed By:

A2A Integrated Pharmaceuticals

Franklin, KY 42134

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAPSAICIN CREAM 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73141-558
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)
XANTHAN GUM (UNII: TTV12P4NEE)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73141-558-02	1 in 1 BOX	03/25/2024
1		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/25/2024

Labeler - A2A Integrated Pharmaceuticals, LLC (117064671)