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NDC 36800-0894-01 TopCare Maximum Strength Pain Relieving 160 mg/mL Details

TopCare Maximum Strength Pain Relieving 160 mg/mL

TopCare Maximum Strength Pain Relieving is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	36800-0894
Product ID	36800-894_8c6d8d77-7bc4-45a2-a13e-019adc036ceb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	TopCare Maximum Strength Pain Relieving
Proprietary Name Suffix	Analgesic
Non-Proprietary Name	MENTHOL, UNSPECIFIED FORM
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	160
Active Ingredient Units	mg/mL
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	Topco Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0894-01 (36800089401)

Pricing Information	N/A
NDC Package Code	36800-894-01
Billing NDC	36800089401
Package	1 BOTTLE, WITH APPLICATOR in 1 CARTON (36800-894-01) / 74 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2020-03-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Menthol 16%

Purpose

Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with:

♦: simple backache
♦: arthritis
♦: strains
♦: bruises
♦: sprains

Warnings

For external use only. Test on a small patch of skin before applying generously.

When using this product

♦: use only as directed
♦: avoid contact with the eyes and mucous membranes
♦: do not apply to wounds or damaged skin
♦: do not bandage tightly
♦: do not use with heating pads or other heating devices
♦: if redness is present, discontinue use and consult a doctor
♦: if skin irritation occurs, discontinue use
♦: a transient burning sensation may occur upon application but generally disappears in several days

Stop use and consult a doctor if condition worsens, or if 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. If swallowed, get medical help or contact a Poison Control Center (1-800222-1222) immediately.

Directions

adults and children 12 years of age and older:

♦: apply generously to affected area
♦: massage into painful area until thoroughly absorbed into skin
♦: repeat if necessary, but not more than 3 to 4 times daily
♦: IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Children 12 years or younger: ask a doctor

Other information

store at room temperature

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, water.

Questions or comments?

1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

NDC 36800-894-01

TopCare

health®

COMPARE TO ICY HOT® ACTIVE INGREDIENT*

MAXIMUM STRENGTH

Cool n' Heat

Roll-On Liquid

External Analgesic

with Menthol 16%

STAIN FREE

Powerful, Fast &

Effective Pain Relief
No-Mess Applicator
Keeps Hands Clean

OUR PHARMACISTS

RECOMMEND

2.5 FL OZ (74 mL)

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

INGREDIENTS AND APPEARANCE

TOPCARE MAXIMUM STRENGTH PAIN RELIEVING ANALGESIC

menthol, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-894
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	160 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
Alcohol (UNII: 3K9958V90M)
Capsaicin (UNII: S07O44R1ZM)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-894-01	1 in 1 CARTON	03/25/2020
1		74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	03/25/2020

Labeler - Topco Associates LLC (006935977)

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Sigan Industries INC.		255106239	MANUFACTURE(36800-894)

Revised: 1/2022

Document Id: 8c6d8d77-7bc4-45a2-a13e-019adc036ceb

Set id: dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab

Version: 3

Effective Time: 20220127

Search by Drug Name or NDC

NDC 36800-0894-01 TopCare Maximum Strength Pain Relieving 160 mg/mL Details

TopCare Maximum Strength Pain Relieving 160 mg/mL

Product Information

Package

Package Images

NDC 36800-0894-01 (36800089401)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab Details

SPL UNCLASSIFIED SECTION

Active ingredients

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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