Capsaicin Cream

Capsaicin Cream
SPL v6
SPL
SPL Set ID 4dedfc37-fead-410d-a5d4-48a4de8fc432
Route
TOPICAL
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.1 g)
Inactive Ingredients
Benzyl Alcohol Isopropyl Myristate Cetyl Alcohol Peg-40 Stearate Glyceryl Monostearate Sorbitol Petrolatum Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-21

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Uses

temporarily relieves minor pain associated with:

  • arthritis

  • simple backache

  • muscle strains

  • sprains

  • bruises
Section 42229-5

Drug Facts

Warnings

For external use only

Directions

adults and children over 18 years:

  • apply to affected area

  • massage into painful area until thoroughly absorbed

  • repeat if necessary, but no more than 3 to 4 times daily

  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 18 years or younger: ask a doctor

  • store at 15°-25°C (59°-77°F)
Active Ingredient

Capsaicin 0.1%

Inactive Ingredients

benzyl alcohol, isopropyl myristate, cetyl alcohol, PEG-40 stearate, glyceryl stearate, sorbitol, petroleum jelly, water

Questions: Or Comments

1-800-697-3329

Manufactured for and Distributed by:

Nationwide Pharmaceutical


San Antonio, TX, 78216

When Using This Product
  • If you are a first time user and think your skin might be sensitive to Capsaicin, test it on a small area first

  • rare cases of serious burns have been reported with products of this type

  • do not bandage tightly or apply local heat (such as heating pads) to the area of use

  • avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skln

  • a transient burning sensation may occur upon application but generally disappears in several days

  • if severe burning occurs, discontinue use immediately and read inside carton for important Information

  • do not expose the area treated with product to heat or direct sunlight do not use al the same time as other topical analgesics

  • use only as directed. Read and follow all directions and warnings on this carton

  • do not use if you are allergic to capsaicin or chili peppers
Stop Use and Ask A Doctor If
  • condition worsens

  • redness is present

  • irritation develops

  • symptoms persist for more than 7 days or clear up and occur again within a few days

  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Principal Display Panel 56.6 G Tube Carton

Nationwide

Pharmaceutical

• Deep Penetrating • Odor Free

NDC# 69375-0006-60

CAPSAICIN HP

High Potency

CAPSAICIN 0.1% / TOPICAL ANALGESIC CREAM

ARTHRITIS PAIN RELIEF

Compare to the

active ingredient

in Capzasin HP®††

NET WT 2.0 oz (56.6 g)


Structured Label Content

Uses

temporarily relieves minor pain associated with:

  • arthritis

  • simple backache

  • muscle strains

  • sprains

  • bruises
Section 42229-5 (42229-5)

Drug Facts

Purpose

Topical analgesic

Warnings

For external use only

Directions

adults and children over 18 years:

  • apply to affected area

  • massage into painful area until thoroughly absorbed

  • repeat if necessary, but no more than 3 to 4 times daily

  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 18 years or younger: ask a doctor

  • store at 15°-25°C (59°-77°F)
Active Ingredient (Active ingredient)

Capsaicin 0.1%

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, isopropyl myristate, cetyl alcohol, PEG-40 stearate, glyceryl stearate, sorbitol, petroleum jelly, water

Questions: Or Comments (Questions: or comments)

1-800-697-3329

Manufactured for and Distributed by:

Nationwide Pharmaceutical


San Antonio, TX, 78216

When Using This Product (When using this product)
  • If you are a first time user and think your skin might be sensitive to Capsaicin, test it on a small area first

  • rare cases of serious burns have been reported with products of this type

  • do not bandage tightly or apply local heat (such as heating pads) to the area of use

  • avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skln

  • a transient burning sensation may occur upon application but generally disappears in several days

  • if severe burning occurs, discontinue use immediately and read inside carton for important Information

  • do not expose the area treated with product to heat or direct sunlight do not use al the same time as other topical analgesics

  • use only as directed. Read and follow all directions and warnings on this carton

  • do not use if you are allergic to capsaicin or chili peppers
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens

  • redness is present

  • irritation develops

  • symptoms persist for more than 7 days or clear up and occur again within a few days

  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Principal Display Panel 56.6 G Tube Carton (PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton)

Nationwide

Pharmaceutical

• Deep Penetrating • Odor Free

NDC# 69375-0006-60

CAPSAICIN HP

High Potency

CAPSAICIN 0.1% / TOPICAL ANALGESIC CREAM

ARTHRITIS PAIN RELIEF

Compare to the

active ingredient

in Capzasin HP®††

NET WT 2.0 oz (56.6 g)


Advanced Ingredient Data


Raw Label Data

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