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NDC 49035-0847-05 Equate Antibiotic Plus Pain Relief 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g Details

Equate Antibiotic Plus Pain Relief 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g

Equate Antibiotic Plus Pain Relief is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by WalMart. The primary component is NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.

Product Information

NDC	49035-0847
Product ID	49035-847_c848ec9e-68b7-4b8f-bd0d-0e49f3a2ab91
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	Equate Antibiotic Plus Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Neomycin sulfate, Polymyxin B Sulfate, and 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	WalMart
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 49035-0847-05 (49035084705)

Pricing Information	N/A
NDC Package Code	49035-847-05
Billing NDC	49035084705
Package	1 TUBE in 1 CARTON (49035-847-05) / 14 g in 1 TUBE
Marketing Start Date	2018-10-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e08b427f-d070-4521-ad3c-faf295531791 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each gram)	Purpose
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	External analgesic

Uses

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

cuts
scrapes
burns

Warnings

For external use only.

Not for prolonged use.

Do not use

in the eyes, nose, or over large areas of the body
if you are allergic to any of the ingredients
longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

condition persists for more than 7 days, gets worse, or clears up and occurs again within a few days
a rash or other allergic reaction develops
redness, irritation, swelling, or pain persists or increases

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 right away: 800-222-1222.

Directions

Adults and children 2 years of age and 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
the affected area may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Other information

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

cetearyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, purified water

Questions or comments?

1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

NDC 49035-847-05

equate™

Compare to

Neosporin®+

Pain Relief

Active

Ingredients*

Maximum Strength

Antibiotic

Cream

+ Pain Relief

Neomycin Sulfate,

Polymyxin B Sulfate,

Pramoxine HCl

First Aid Antibiotic /

Pain Relieving Cream

Soothes painful cuts,

scrapes and burns

while preventing

infection

Made in the

USA

Factory Certified

NET WT

0.5 OZ (14.2g)

Principal Display Panel - 14.2 g Tube Carton

INGREDIENTS AND APPEARANCE

EQUATE ANTIBIOTIC PLUS PAIN RELIEF

neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-847
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Neomycin sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin sulfate	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
cetostearyl alcohol (UNII: 2DMT128M1S)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
petrolatum (UNII: 4T6H12BN9U)
polysorbate 60 (UNII: CAL22UVI4M)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-847-05	1 in 1 CARTON	10/18/2018
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	10/18/2018

Labeler - WalMart (051957769)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(49035-847)

Revised: 1/2022

Document Id: c848ec9e-68b7-4b8f-bd0d-0e49f3a2ab91

Set id: e08b427f-d070-4521-ad3c-faf295531791

Version: 2

Effective Time: 20220119

Search by Drug Name or NDC

NDC 49035-0847-05 Equate Antibiotic Plus Pain Relief 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g Details

Equate Antibiotic Plus Pain Relief 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g

Product Information

Package

Package Images

NDC 49035-0847-05 (49035084705)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e08b427f-d070-4521-ad3c-faf295531791 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

INGREDIENTS AND APPEARANCE

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