Parche Leon Hot (novamed)

SPL v4

SPL

SPL Set ID a8f266fa-6e43-559e-e053-2995a90a2c75

Route

TOPICAL

Published

Effective Date 2020-02-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Capsaicin (0.025 g) Camphor (synthetic) (3 g) Menthol, Unspecified Form (1.25 g)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-02-28

Description

Active ingredients (in each patch) Purpose Camphor 3%............................................................. External analgesic Menthol 1.25%.......................................................... External analgesic Capsaicin 0.025%..................................... External analgesic

Medication Information

Description

Uses

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

simple back aches
arthritis
strains
bruises
sprains

Section 55105-1

Active ingredients (in each patch)	Purpose
Camphor 3%.............................................................	External analgesic
Menthol 1.25%..........................................................	External analgesic
Capsaicin 0.025%.....................................	External analgesic

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with eyes.

Directions

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: do not use, consult a doctor
clean and dry affected area
remove patch from film
apply sticky side of patch to affected area
use one patch at a time
leave patch on affected area for up to 8-hours at a time

Do Not Use

on wounds or damaged skin
with a tight bandage
on sensitive skin
if allergic to any ingredients in this product

Drug Facts

Other Information

store between 59-86°F (15-30°C)
do not store in direct sunlight or expose to excessive heat
Do not use if packet containing the patch is torn or broken

Inactive Ingredients

None

Questions Or Comments?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

Stop Use and Ask A Doctor If

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness is present

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

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

simple back aches
arthritis
strains
bruises
sprains

Section 55105-1 (55105-1)

Active ingredients (in each patch)	Purpose
Camphor 3%.............................................................	External analgesic
Menthol 1.25%..........................................................	External analgesic
Capsaicin 0.025%.....................................	External analgesic

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with eyes.

Directions

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: do not use, consult a doctor
clean and dry affected area
remove patch from film
apply sticky side of patch to affected area
use one patch at a time
leave patch on affected area for up to 8-hours at a time

Do Not Use (Do not use)

on wounds or damaged skin
with a tight bandage
on sensitive skin
if allergic to any ingredients in this product

Drug Facts

Other Information (Other information)

store between 59-86°F (15-30°C)
do not store in direct sunlight or expose to excessive heat
Do not use if packet containing the patch is torn or broken

Inactive Ingredients

None

Questions Or Comments? (Questions or Comments?)

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness is present

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 a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "CAPSAICIN", "unii": "S07O44R1ZM", "classCode": "ACTIB", "strengthNumerator": "0.025", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1.25", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For temporary relief of minor aches and pains of muscles and joints associated with simple back aches arthritis strains bruises sprains", "55105-1": "Active ingredients (in each patch) Purpose Camphor 3%............................................................. External analgesic Menthol 1.25%.......................................................... External analgesic Capsaicin 0.025%..................................... External analgesic", "Warnings": "FOR EXTERNAL USE ONLY. Avoid contact with eyes.", "Directions": "adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, consult a doctor clean and dry affected area remove patch from film apply sticky side of patch to affected area use one patch at a time leave patch on affected area for up to 8-hours at a time", "Do not use": "on wounds or damaged skin with a tight bandage on sensitive skin if allergic to any ingredients in this product", "Other information": "store between 59-86°F (15-30°C) do not store in direct sunlight or expose to excessive heat Do not use if packet containing the patch is torn or broken", "Inactive Ingredients": "None", "Questions or Comments?": "1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com", "Stop use and ask a doctor if": "condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:47.684473 · Updated: 2026-03-14T23:08:06.304944