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, Quality CDMO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Capsaicin 0.1%

Purpose

External Analgesic

Uses

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

• simple backache
• arthritis
• strains
• sprains

Warnings

For External use only

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

Do not use:

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

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

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 if swallowed get medical help or contact a Poison Control Center immediately

Directions

Directions

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

Other Information

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

Inactive Ingredients

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 or comments

Questions or comments?

Call (800) 380-6709

Distributed By:

A2A Integrated Pharmaceuticals

Bowling Green, KY 42101

PRINCIPAL DISPLAY PANEL

NDC: 73141-558-02

A2A Integrated Pharmaceuticals

Capsaicin Cream 0.1%

External Analgesic

NET WT. 2.1 oz. (60g)

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

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)

Establishment
Name	Address	ID/FEI	Business Operations
Quality CDMO		117658386	manufacture(73141-558) , pack(73141-558)