CAPSAICIN CREAM 0.075%- capsaicin cream

Capsaicin Cream 0.075% by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Capsaicin Cream 0.075%

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 capsicum 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
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.If swallowed, get medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

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

Other information

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

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, stearate-100, stearic acid, stearyl alcohol, triethanolamine, water

Questions or comments? 1-888-788-6472

Product label

INGREDIENTS AND APPEARANCE

CAPSAICIN CREAM 0.075% 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45861-075
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-100 STEARATE (UNII: YD01N1999R)
PETROLATUM (UNII: 4T6H12BN9U)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45861-075-05	57 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2025

Labeler - Pharmaceutica North America, Inc. (962739699)