TOPCARE PAIN RELIEF MAXIMUM STRENGTH- lidocaine hydrochloride liquid

TopCare Pain Relief by

Drug Labeling and Warnings

TopCare Pain Relief by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCI 4%

Purpose

Topical anesthetic

Uses

• ▪ temporarily relieves minor pain 

Warnings

For external use only

Do not use

• ▪ on large areas of the body or on cut, irritated or swollen skin
• ▪ on puncture wounds
• ▪ for more than one week without consulting a doctor

When using this product

• ▪ use only as directed. Read and follow all directions and warnings on this carton.
• ▪ do not allow contact with the eyes
• ▪ do not bandage or apply local heat (such as heating pads) to the area of use

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

Flammable

• ▪ Keep away from fire or flame

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

adults and children over 12 years:

• ▪ apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

children 12 years and younger: ask a doctor

Inactive ingredients

aloe barbadensis leaf juice. Carbomer, disodium EDTA, glycerin, phenyl carbinol, purified water, sodium hydroxide.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

NDC# 36800-529-25

Compare to the active ingredient in Aspercreme® Odor Free with 4 % Lidocaine*

MAXIMUM STRENGTH

PAIN RELIEF Roll-On Liquid

Lidocaine HCl 4%

Odor Free

• Temporary relief of pain
• Helps pain-affected areas
• No-touch applicator
• Oil-Free
• Paraben-Free
• Alcohol-Free

With Aloe

NET WT 2.5 OZ (71 g)

CHILD-RESISTANT PACKAGING. CLOSE CAP TIGHTLY AFTER USE.

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 6007

TOPCO RSE515

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

*This product is not manufactured or distributed by Chattern, Inc., owner of the registered trademark Aspercreme® Odor Free with 4% Lidocaine.

INGREDIENTS AND APPEARANCE

TOPCARE PAIN RELIEF  MAXIMUM STRENGTH
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-529
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-529-25	1 in 1 CARTON	04/12/2019
1		71 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/12/2019

Labeler - TOPCO ASSOCIATES (006935977)