Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID cc3fdc61-8823-48a5-ab65-8366e2fbf04a
Route
TOPICAL
Published
Effective Date 2017-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (.025 mg)
Inactive Ingredients
(c10-c30)alkyl Methacrylate Ester Aloe Vera Leaf Water Arnica Montana Boswellia Serrata Resin Oil Cetyl Alcohol Ethylhexylglycerin Isopropyl Myristate Polyethylene Glycol 800 Phenoxyethanol Polysorbate 20 Triethanolamine Glutamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-10

Description

Active Ingredient Capsaicin 0.025%

Purpose

Purpose Topical Analgesic


Medication Information

Purpose

Purpose

Topical Analgesic

Description

Active Ingredient Capsaicin 0.025%

Uses

Uses

for the temporary relief of minor aches and painsof muscles and joints associated with a simple backache,

athritis, strains and sprains

Section 44425-7

WARNING: FLAMMABLE PRODUCT

Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

Section 50565-1

If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

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

If inhaled, remove the fresh air. If breathing is difficult, get medical attention immediately.

Section 51945-4

Section 53413-1

FOR QUESTIONS OR COMMENTS:

[email protected]

Warnings

Warnings

For external use only

  • This is not a face cream. Do not apply to the face.
  • Do not use if allergic to chili peppers or if past allergic reaction to capsaicin
  • Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
  • Do not bandage tightly
  • Do not apply within 1 hour before or after bath, shower, hot tub, saunaor vigrous exercise
  • Warm water, perspiration or open pores can intensify the impact of this product and bruning sensation.
  • Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

When using this product  Do not get into eyesand avoid contact with mucous membranes. If contact

occurs or if pain, discomfort or skin redness occurs, continuously rinse with cool water and seek medical help.

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear

up and occur again within a few days. Stop using and get immediate medical attention if experience burning,

pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported.

Directions

Directions

  • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
  • Before using on children under 18 years of age consult a physician.
  • Apply sparingly to affected area not more than 4 times daily. However, for the first use, apply to small area to test for sensitivity or skin reaction.
  • Gently massage into skin until fully absorbed.
  • Wash hands with soap and water thoroughly after each applicationto avoid spreading to the eyes or other sensitive mucous membranes.
Active Ingredient

Active Ingredient

Capsaicin 0.025%

Inactive Ingredients

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice,

Aqua (Deionized Water), Arnica Montana Extract, Bosswellia Serrata Extract,

Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8,

Phenoxyethanol, Polysorbate-20, Triethanolamine


Structured Label Content

Uses

Uses

for the temporary relief of minor aches and painsof muscles and joints associated with a simple backache,

athritis, strains and sprains

Section 44425-7 (44425-7)

WARNING: FLAMMABLE PRODUCT

Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

Section 50565-1 (50565-1)

If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

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

If inhaled, remove the fresh air. If breathing is difficult, get medical attention immediately.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

FOR QUESTIONS OR COMMENTS:

[email protected]

Purpose

Purpose

Topical Analgesic

Warnings

Warnings

For external use only

  • This is not a face cream. Do not apply to the face.
  • Do not use if allergic to chili peppers or if past allergic reaction to capsaicin
  • Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
  • Do not bandage tightly
  • Do not apply within 1 hour before or after bath, shower, hot tub, saunaor vigrous exercise
  • Warm water, perspiration or open pores can intensify the impact of this product and bruning sensation.
  • Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

When using this product  Do not get into eyesand avoid contact with mucous membranes. If contact

occurs or if pain, discomfort or skin redness occurs, continuously rinse with cool water and seek medical help.

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear

up and occur again within a few days. Stop using and get immediate medical attention if experience burning,

pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported.

Directions

Directions

  • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
  • Before using on children under 18 years of age consult a physician.
  • Apply sparingly to affected area not more than 4 times daily. However, for the first use, apply to small area to test for sensitivity or skin reaction.
  • Gently massage into skin until fully absorbed.
  • Wash hands with soap and water thoroughly after each applicationto avoid spreading to the eyes or other sensitive mucous membranes.
Active Ingredient

Active Ingredient

Capsaicin 0.025%

Inactive Ingredients

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice,

Aqua (Deionized Water), Arnica Montana Extract, Bosswellia Serrata Extract,

Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8,

Phenoxyethanol, Polysorbate-20, Triethanolamine


Advanced Ingredient Data


Raw Label Data

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