PAIN RELIEF HOT PATCH- menthol and capsaicin patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)

Available from:

Universal Distribution Center LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic Temporarily relieves minor pain associated with: - arthritis • simple backache • bursitis • tendonitis • muscle strains • bruises • cramps

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAIN RELIEF HOT PATCH- MENTHOL AND CAPSAICIN PATCH
UNIVERSAL DISTRIBUTION CENTER LLC
_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._
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PAIN RELIEF HOT PATCH
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH GRAM)
Menthol 30 mg
Capsaicin 0.83 mg
PURPOS E
Topical Analgesic
US ES
Temporarily relieves minor pain associated with:
arthritis • simple backache • bursitis • tendonitis • muscle
strains • bruises • cramps
WARNINGS:
EXTERNAL USE ONLY
WHEN USING THIS PRODUCT • use only as directed • do not bandage
tightly or use with a heating pad •
avoid contact with eyes and mucous membranes • do not apply to
wounds or damaged skin.
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 • skin
irritation develops
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
(1-800-222-1222) immediately.
DIRECTIONS
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER:
• Partially peel back protective film and apply exposed patch to
site of pain. Carefully remove remaining
film while pressing patch to skin for secure adhesions
• Apply to affected area not more than 3 to 4 times a daily
CHILDREN UNDER 12 YEARS OF AGE: DO NOT use without consulting a
doctor.
OTHER INFORMATION
• store at room temperature 68° to 77°F (20 to 25°C)
INACTIVE INGREDIENTS
glycerin, sodium polyacrylate, aluminum glycinate, kaolin,
methylparaben, propylparaben, alcohol,
titanium dioxide, tartaric acid, sorbitan monooleate, polysorbate 80,
purified water
EXTRA STRENGTH PAIN RELIEF HOT PATCH SOOTHES AND RELIEVES PAIN
ASSOCIATED WITH
MINOR ACHES AND PAINS. IT IS IDEAL FOR SMALL AREAS SUCH AS ARM, NECK
AND LEG.
FAST-ACTING PAIN RELIEF
DISTRIBUTED BY:
Universal Distributio