PAINBLOC24 FLEXI-STRETCH PAIN TAPE- lidocaine patch

PainBloc24 Flexi-Stretch Pain Tape by

Drug Labeling and Warnings

PainBloc24 Flexi-Stretch Pain Tape by is a Otc medication manufactured, distributed, or labeled by VIZURI HEALTH SCIENCES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

For Temporary Relief of Pain.

Warnings

For external use only

Do not use:

•  more than 3 strips at a time
• on damaged, broken or irritated skin
•  with a heating pad
•  if you are allergic to any of the ingredients in this product

When using this product use only as directed:

•  do not bandage tightly
•  avoid contact with eyes and mucous membranes
•  dispose of used strips in a manner that keeps them away from children or pets so they are not accidentally ingested or chewed

Stop use and ask a doctor if:

•  condition worsens
•  redness or irritation develops
•  you experience localized skin reactions such as rash, itching, pain, swelling or blistering
•  symptoms last more than 7 days or clear up and occur again within a few days

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 right away.

Directions

Adults and Children 12 years and older

•  Clean and dry affected area
•  Trim excessive hair for better adhesion
•  Remove roll from container and remove outer wrap
•  Tear off 1 or 2 strips from roll. See illustration for instructions on removing the backing and applying to skin.
•  Apply no more than 3 strips at a time, no more than 2 times a day
•  Some individuals may not experience pain relief until several minutes or hours after applying
•  Seal remaining roll with resealable tab, return to container and close cap securely
•  Use strip as needed for up to 12 hours. Do not remove when wet or directly after showering or bathing. Allow strip to dry and then remove.

Children under 12 years: consult a doctor

Inactive Ingredients

aloe barbadensis (aloe vera) leaf juice, arnica montana flower extract, boswellia, calendula, lavender, methylsulfonylmethane (MSM),peppermint oil,polybutene,polysorbate 80,tocopheryl acetate (vitamin E),water,white curcumin

PRINCIPAL DISPLAY PANEL

Product label

Product label

INGREDIENTS AND APPEARANCE

PAINBLOC24 FLEXI-STRETCH PAIN TAPE 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71226-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BOSWELLIA FREREANA WHOLE (UNII: 795ST8633Q)
CALENDULA ARVENSIS LEAF (UNII: 3U3U118F2L)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CURCUMIN (UNII: IT942ZTH98)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71226-002-01	10 in 1 CANISTER; Type 0: Not a Combination Product	06/25/2020	09/30/2021
2	NDC: 71226-002-10	5 in 1 CANISTER; Type 0: Not a Combination Product	06/25/2020
3	NDC: 71226-002-17	10 in 1 CARTON; Type 0: Not a Combination Product	09/30/2021
4	NDC: 71226-002-09	10 in 1 CARTON; Type 0: Not a Combination Product	06/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/25/2020

Labeler - VIZURI HEALTH SCIENCES LLC (052129499)