Leader Capsaicin Pain Relief Cream

Leader Capsaicin Pain Relief Cream
SPL v9
SPL
SPL Set ID a5620709-0fed-4979-e053-2a95a90ac654
Route
TOPICAL
Published
Effective Date 2020-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.1 g)
Inactive Ingredients
Glycerin Glyceryl Monostearate Petrolatum Water Sodium Lauryl Sulfate Aloe Vera Leaf Ethylparaben Mineral Oil Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-11

Description

Capsaicin 0.1%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.1%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Arthritis
  • Simple Backache
  • Strains
  • Sprains
  • Bruises
Section 51945-4

Warnings

For external use only: TEST FIRST ON SMALL AREA OF SKIN.

When using this product:

  • Use only as directed
  • Do not apply to wounds, damaged, broken or irritated sin
  • Do not use if you are allergic to capsicum or chili peppers
  • Avoid contact with the eyes or mucous membranes
  • A slight burning sensation may occur upon application, but generally disappears in several days
  • If severe burning occurs, discontinue use
  • Do not expose the treated area to heat or direct sunlight
  • Do not bandage
  • Do not use with heating pad
  • Do not use at the same time as other topical analgesics
Questions

1 (800) 200- 6313

Distributed by

Cardinal Health

Dublin, Ohio 43017

This product is not manufactured or distrubuted by Chattem Inc. owner of registered trademark Capzasin HP, 2020 Cardinal Health Leader and Logos are trademarks of Cardinal Health. All other marks are the property of their respective owners

www.myleader.com

Made in China

Directions

Adults and Children over 18 years:

  • Apply to affected area
  • Massage into the painful area until thoroughly absorbed
  • Repeat as necessary but not more than 3 to 4 times daily
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Children 18 years and younger:

Ask a doctor

Active Ingredient

Capsaicin 0.1%

Other Information

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

Inactive Ingredients

Aloe barbadensis leaf juice, Ethylparaben, Glycerin, Clyceryl monostearate, Mineral Oil, Octadecyl alcohol, Petrolatum, Purified Water, Sodium lauryl Sulfate

Stop Use and Ask Doctor

Stop Use and Ask Doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present
  • irritation develops
If Pregnant Or Breast Feeding

Ask a doctor before use

Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Arthritis
  • Simple Backache
  • Strains
  • Sprains
  • Bruises
Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Warnings

For external use only: TEST FIRST ON SMALL AREA OF SKIN.

When using this product:

  • Use only as directed
  • Do not apply to wounds, damaged, broken or irritated sin
  • Do not use if you are allergic to capsicum or chili peppers
  • Avoid contact with the eyes or mucous membranes
  • A slight burning sensation may occur upon application, but generally disappears in several days
  • If severe burning occurs, discontinue use
  • Do not expose the treated area to heat or direct sunlight
  • Do not bandage
  • Do not use with heating pad
  • Do not use at the same time as other topical analgesics
Questions

1 (800) 200- 6313

Distributed by

Cardinal Health

Dublin, Ohio 43017

This product is not manufactured or distrubuted by Chattem Inc. owner of registered trademark Capzasin HP, 2020 Cardinal Health Leader and Logos are trademarks of Cardinal Health. All other marks are the property of their respective owners

www.myleader.com

Made in China

Directions

Adults and Children over 18 years:

  • Apply to affected area
  • Massage into the painful area until thoroughly absorbed
  • Repeat as necessary but not more than 3 to 4 times daily
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Children 18 years and younger:

Ask a doctor

Active Ingredient

Capsaicin 0.1%

Other Information

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

Inactive Ingredients

Aloe barbadensis leaf juice, Ethylparaben, Glycerin, Clyceryl monostearate, Mineral Oil, Octadecyl alcohol, Petrolatum, Purified Water, Sodium lauryl Sulfate

Stop Use and Ask Doctor

Stop Use and Ask Doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present
  • irritation develops
If Pregnant Or Breast Feeding (If Pregnant or Breast Feeding)

Ask a doctor before use

Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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