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]

Drug Facts

Active Ingredient

Capsaicin 0.1%

Purpose

Topical Analgesic

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 capsicum or chili peppers
• do not use with heating pad or expose area to sunlight

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 treatment area
• do not apply heat to the treated area immediately before or after use

Stop Use and Ask Doctor

Stope Use and Ask Doctor if:

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

Keep Out of the Reach of Children

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

Uses

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

• simple backache
• arthritis
• strains
• sprains

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

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

Questions? Comments?

1-855-361-3993

Manufactured for:

AvKARE, Pulaski, TN 38478

www.avkare.com

AV 06/22

Other Information

Store at room temperature 15°-30°F (59°-86°F)

Packaging

INGREDIENTS AND APPEARANCE

CAPSAICIN 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50268-198
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
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
MINERAL OIL (UNII: T5L8T28FGP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50268-198-42	1 in 1 CARTON	12/08/2022
1		42.5 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)