Capsaicin by AvPAK CAPSAICIN cream

Capsaicin by

Drug Labeling and Warnings

Capsaicin by is a Otc medication manufactured, distributed, or labeled by AvPAK. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Capsaicin 0.1%

PURPOSE

Purpose: Topical Analgesic

INDICATIONS & USAGE

Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

WARNINGS

Warnings: For external use only.

Do not use:

• on wounds or damaged skin
• if you are allergic to capsicum or chili peppers
• with heating pad

When using this produce:

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

Stop use and ask a doctor if:

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions – Adults and children 18 years of age and older

• apply a thin film of cream to affected area and gently rub 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

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

SPL UNCLASSIFIED SECTION

Questions? Comments?

1-855-361-3993

Manufactured for:

AvKARE, Pulaski, TN 38478

www.avkare.com

AV 06/22

Packaging

INGREDIENTS AND APPEARANCE

CAPSAICIN 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50268-197
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.001 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PETROLATUM (UNII: 4T6H12BN9U)
PEPPERMINT OIL (UNII: AV092KU4JH)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
XANTHAN GUM (UNII: TTV12P4NEE)
MINERAL OIL (UNII: T5L8T28FGP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50268-197-56	1 in 1 CARTON	12/08/2022
1		56.6 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	12/08/2022

Labeler - AvPAK (832926666)