Walgreens Capsaicin Hot: Package Insert and Label Information

WALGREENS CAPSAICIN HOT- capsaicin patch
Walgreen Co

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient Purpose

Capsaicin extract 0.025% as Capsaicin……………………………….Topical Analgesic

Uses Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

  • For external use only
  • Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product.

Do not use

  • on wounds or damaged skin
  • with a heating pad

When using this product

  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Stop use and ask a doctor if

  • conditions worsens, symptoms persist more than 7 days or clear up and occur again within a few days
  • redness is present or irritation or rash develops
  • a severe burining sensation occurs

If pregnant or breast-feeding, ask a healthcare professional before use.

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

Directions

  • adults and children 12 years of age and older:
  • clean and dry affected area
  • remove patch from film
  • apply to affected area no more than 3 to 4 times daily
  • do not wear patch for more than 8 hours
  • children under 12 years of age: consult a doctor

Other information

  • avoid storing product in direct sunlight
  • protect product from excessive moisture

butylhydroxytoluene, glyceryl rosinate, isopropyl myristate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, propylene carbonate, sorbitan stearate, terpene resin (quinton), terpene resin (ys resin), titanium dioxide, zinc oxide

Questions or comments?

Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)

Distributed By:

Walgreen Co

200 Wilmot Rd.

Deerfield, IL 60005

Made in South Korea

541902
(click image for full-size original)

WALGREENS CAPSAICIN HOT
capsaicin extract patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9113
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.6 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
GLYCERYL ROSINATE
POLYISOBUTYLENE (1100000 MW)
POLYBUTENE (1400 MW)
BUTYLATED HYDROXYTOLUENE
ISOPROPYL MYRISTATE
NATURAL LATEX RUBBER
PROPYLENE CARBONATE
SORBITAN MONOSTEARATE
TITANIUM DIOXIDE
ZINC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-9113-03 3 PATCH in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/30/2013
Labeler — Walgreen Co (008965063)

Revised: 12/2018 Walgreen Co

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