CAPSAICIN 0.075% CREAM- capsaicin cream

Capsaicin 0.075% Cream by

Drug Labeling and Warnings

Capsaicin 0.075% Cream by is a Otc medication manufactured, distributed, or labeled by ViolaCare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts Active Ingredient  Purpose

Capsaicin 0.075%.............................................Topical Analgesic

PURPOSE

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 the skin.

Do not use

• on wounds or damaged skin
• if you are allergic to capsaicum 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 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

Stop use and ask doctor if

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

DOSAGE & ADMINISTRATION

Directions adults and children 18 years and older:

• apply a thin film of cream to the 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

ASK DOCTOR

Other information

Store at 20° C-25° C (68° F-77° F); excursions permitted to 15° C-30° C (59° F-86° F). See USP Controlled Room Temperature.

Inactive Ingredients

aloe barbadensis leaf juice, cetyl alcohol, glyceryl stearate, mineral oil, PEG-100 stearate, peppermint oil, petrolatum, phenoxyethanol, propylene glycol, stearyl alcohol, water, xanthan gum

KEEP OUT OF REACH OF CHILDREN

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

SPL UNCLASSIFIED SECTION

Questions? Call 877-227-3137

PRINCIPAL DISPLAY PANEL

Capsaicin 0.075% Cream - NDC: 85231-202-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g) Tube Label

Capsaicin 0.075% Cream - NDC: 85231-202-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g) Carton Label

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054

INGREDIENTS AND APPEARANCE

CAPSAICIN 0.075% CREAM 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85231-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.075 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PEPPERMINT OIL (UNII: AV092KU4JH)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85231-202-60	1 in 1 CARTON	06/02/2025
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	06/02/2025

Labeler - ViolaCare, Inc. (119452160)