Drugplain

Pain Relieving Cream 3 mg/100mL

Camphor and Menthol · CREAM · GOLDEN TIGER DISTRIBUTION L.L.C.

7 Recalls on Record
Plain English

Pain Relieving Cream is a cream containing camphor and menthol at 3 mg/100mL, taken topical. Manufactured by GOLDEN TIGER DISTRIBUTION L.L.C..

Key Facts

Brand Name
Pain Relieving Cream
Generic Name
Camphor and Menthol
NDC Code (Product)
84334-000
Manufacturer
GOLDEN TIGER DISTRIBUTION L.L.C.
Strength
3 mg/100mL
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
12/02/2004

Recall History

7 Recalls on Record
Class II08/02/2023

Parker Laboratories, Inc.

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class III10/30/2017

Dr. Reddy's Laboratories, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle

TerminatedVoluntary: Firm initiated
Class II04/17/2024

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

OngoingVoluntary: Firm initiated
Class II04/17/2024

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

OngoingVoluntary: Firm initiated
Class II04/17/2024

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

OngoingVoluntary: Firm initiated
Class II04/17/2024

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

OngoingVoluntary: Firm initiated
Class III03/07/2013

Novartis Consumer Health

Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3,771 reports
pain3,240 reports
fatigue3,035 reports
nausea3,009 reports
headache2,806 reports
off label use2,588 reports
dyspnoea2,177 reports
pneumonia1,988 reports
sinusitis1,960 reports
diarrhoea1,956 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporary Pain Relief

Dosage & Administration

Directions Adults and children over 12 years clean and dry affected area Apply to affected area not more than 3 to 4 times daily Children 12 years or younger ask a doctor

Warnings

Warnings For external Use Only Do not use in eyes in large quantities over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns for more than one week unless directed by a doctor

Frequently Asked Questions

What is Pain Relieving Cream used for?

Pain Relieving Cream contains Camphor and Menthol. It is a cream taken topical. Consult your doctor for specific uses.

Is Pain Relieving Cream a controlled substance?

Pain Relieving Cream is not classified as a controlled substance by the DEA.

What is the generic name for Pain Relieving Cream?

The generic name for Pain Relieving Cream is Camphor and Menthol. There are 11 other brand versions of Camphor and Menthol.

What is the NDC code for Pain Relieving Cream 3 mg/100mL?

The NDC (National Drug Code) for Pain Relieving Cream 3 mg/100mL is 84334-000, listed by GOLDEN TIGER DISTRIBUTION L.L.C..