PERFORMANCE BRANDS STEEL RELEAF PAIN RELIEVING LIQUID- lidocaine hydrochloride, menthol liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

Prime Enterprises, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic For temporary relief of pain

Authorization status:

OTC monograph not final

Summary of Product characteristics

PERFORMANCE BRANDS STEEL RELEAF PAIN RELIEVING LIQUID- LIDOCAINE
HYDROCHLORIDE, MENTHOL LIQUID
PRIME ENTERPRISES, INC.
_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._
----------
STEEL RELEAF PAIN RELIEVING LIQUID
_ACTIVE INGREDIENTS_
Lidocaine Hydrochloride 4%
Menthol 1%
_PURPOSE_
Topical Analgesic
_USES_
For temporary relief of pain
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE
More than one recommended dose at a time
On broken or irritated skin
If you are allergic to any ingredients of this product
In large quantities, particularly over raw surfaces or blistered areas
WHEN USING THIS PRODUCT
Use only as directed
Avoid contact with eyes
Do not wrap the treated skin with plastic wrap or other dressings or
apply heat to the
skin
STOP USE AND ASK A DOCTOR IF
Condition worsens or symptoms persist for more than 7 days or clear up
and occurs
again
Skin reactions occur, such as rash, itching, redness or irritation
IF PREGNANT OR BREASTFEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. If product is swallowed, get medical
help or contact a
Poison Control Center right away.
_DIRECTIONS_
ADULTS AND CHILDREN 12 YEARS AND OVER
Clean and dry affected area
Apply once, not to exceed 3 to 4 times daily
Roll on affected area of skin
Children under 12 years of age: Consult a doctor
_OTHER INFORMATION_
Store at 20-25°C (68-77°F)
Avoid storing product in direct sunlight
Protect product from excessive moistre
You may report serious side effects to [phone]
_INACTIVE INGREDIENTS_
Acrylamide/Sodium Acrylate Copolymer, Aesculus Hippocastanum (Horse
Chestnut)
Seed Extract, Arnica Montana Flower Extract, Borago Officinalis Seed
Oil, Boswellia
Serrata Extract, Camellia Oleifera (Green Tea) Leaf Extract, Hemp
Derived Isolate (HDI),
Chamomilla Recutita (Matricaria) Flower Extract, Curcuma Longa
(Turmeric) Root
Extract, Glycerin, Harpagophytum Pro