rugby capsaicin cream

rugby capsaicin cream
SPL v5
SPL
SPL Set ID 9eca34f1-e91a-3ac1-e053-2a95a90a9bd9
Route
topical
Published
Effective Date 2023-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
capsaicin (0.1 g)
Inactive Ingredients
aloe vera leaf ethylparaben mineral oil stearyl alcohol water glycerin glyceryl monostearate petrolatum laureth-15 cetostearyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-02-17

Purpose

Topical Analgesic

Description

Capsaicin 0.1%


Medication Information

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 capssicum or chili peppers
  • Avoid contact with the eyes or mucous membranes
  • A slight burning sensation may occur upon application, but generally disappears after several days of use
  • 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
Uses

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

  • Arthritis
  • Simple Backache
  • Strains
  • Sprains
  • Bruises
Purpose

Topical Analgesic

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

Other Information

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

Inactive Ingredients

Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Purified Water, stearic acid.

Description

Capsaicin 0.1%

Packaging

Questions

Call 1-800-645-2158

Distributed By:

RUGBY®LABORATORIES

Livonia, MI 48152

www.rugbylaboratories.com

rev. 09/21 R-167 Re-order No. 370818

Active Ingredient

Capsaicin 0.1%

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

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 capssicum or chili peppers
  • Avoid contact with the eyes or mucous membranes
  • A slight burning sensation may occur upon application, but generally disappears after several days of use
  • 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
Uses

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

  • Arthritis
  • Simple Backache
  • Strains
  • Sprains
  • Bruises
Purpose

Topical Analgesic

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

Other Information

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

Inactive Ingredients

Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Purified Water, stearic acid.

Packaging

Questions

Call 1-800-645-2158

Distributed By:

RUGBY®LABORATORIES

Livonia, MI 48152

www.rugbylaboratories.com

rev. 09/21 R-167 Re-order No. 370818

Active Ingredient

Capsaicin 0.1%

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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