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NDC 36800-0976-58 Topcare Antibiotic 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g Details

Topcare Antibiotic 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g

Topcare Antibiotic is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.

Product Information

NDC	36800-0976
Product ID	36800-976_1da253a6-ba2e-4cc8-8e32-d33944870f99
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 Antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	neomycin, polymyxin B, pramoxine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	3.5; 10000; 10
Active Ingredient Units	mg/g; [USP'U]/g; mg/g
Substance Name	NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0976-58 (36800097658)

Pricing Information	N/A
NDC Package Code	36800-976-58
Billing NDC	36800097658
Package	1 TUBE in 1 CARTON (36800-976-58) / 14 g in 1 TUBE
Marketing Start Date	2020-04-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8c349cac-20e1-4600-9b0a-fcfe929551c5 Details

Active ingredients (in each gram)

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

Purpose

First aid antibiotic

External analgesic

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

•: cuts
•: scrapes
•: burns

Warnings

For external use only.

Do not use

•: if you are allergic to any of the ingredients
•: in the eyes
•: over large areas of the body

Ask a doctor before use if you have

•: deep or puncture wounds
•: animal bites
•: serious burns

Stop use and ask a doctor if

•: you need to use longer than 1 week
•: condition persists or gets worse
•: symptoms persist for more than 1 week, or clear up and occur again within a few days
•: rash or other allergic reaction develops

Keep out of reach of children.

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

Directions

•: adults and children 2 years of age or older:
•: clean the affected area
•: apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
•: may be covered with a sterile bandage
•: children under 2 years of age: ask a doctor

Other information

•: store at 20o-25oC (68o-77oF)

Inactive ingredients

emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

COMPARE TO NEOSPORIN® + PAIN RELIEF ACTIVE INGREDIENTS

First Aid Antibiotic & Pain Relieving Cream

Helps Prevent Infection in Minor Cuts, Scrapes & Burns

Maximum Strength

TopCare® health

MAXIMUM STRENGTH

Antibiotic Cream + Pain Relief

NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCl

First Aid Antibiotic / Pain Relieving Cream

NET WT 0.5 OZ (14 g)

INGREDIENTS AND APPEARANCE

TOPCARE ANTIBIOTIC

neomycin, polymyxin b, pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-976
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U] in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLOXAMER 188 (UNII: LQA7B6G8JG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-976-58	1 in 1 CARTON	04/03/2020
1		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	04/03/2020

Labeler - Topco Associates LLC (006935977)

Revised: 2/2022

Document Id: 1da253a6-ba2e-4cc8-8e32-d33944870f99

Set id: 8c349cac-20e1-4600-9b0a-fcfe929551c5

Version: 3

Effective Time: 20220228