Drugplain

Pain Relieving 3.85 g/100mL

Menthol, Camphor, Capsaicin · LOTION · AHC VENTURES CORP DBA CRY

10 Recalls on Record
Plain English

Pain Relieving is a lotion containing menthol, camphor, capsaicin at 3.85 g/100mL, taken topical. Manufactured by AHC VENTURES CORP DBA CRY.

Key Facts

Brand Name
Pain Relieving
Generic Name
Menthol, Camphor, Capsaicin
NDC Code (Product)
68678-039
Manufacturer
AHC VENTURES CORP DBA CRY
Strength
3.85 g/100mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
01/01/2016

Recall History

10 Recalls on Record
Class II02/24/2023

Ecometics, Inc.

CGMP DEVIATIONS

TerminatedVoluntary: Firm initiated
Class II05/16/2018

Ideaz Llc

CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.

TerminatedVoluntary: Firm initiated
Class II08/02/2023

Parker Laboratories, Inc.

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class I03/23/2024

Aruba Aloe Balm N.V.

Chemical Contamination: Product manufactured with ethanol API that contains methanol

OngoingVoluntary: Firm initiated
Class II10/24/2024

Unexo Life Sciences Private Limited

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 II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II06/21/2019

Pharma-Natural Inc.

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

TerminatedVoluntary: Firm initiated
Class II10/03/2014

Wisconsin Pharmacal Company

Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective12,409 reports
pain11,287 reports
fatigue10,368 reports
off label use8,724 reports
rash7,605 reports
headache7,509 reports
nausea7,202 reports
rheumatoid arthritis6,654 reports
abdominal discomfort6,490 reports
arthralgia6,325 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Dosage & Administration

Directions Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

Warnings

Warnings For external use only Do not use on wounds or damaged skin When using this product avoid contact with the eyes do not bandage tightly Stop use and ask doctor if symptoms persist for more than 7 days or clear up and occur again within a few days condition worsens irritation occurs If pregnant or breastfeeding, 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.

Frequently Asked Questions

What is Pain Relieving used for?

Pain Relieving contains Menthol, Camphor, Capsaicin. It is a lotion taken topical. Consult your doctor for specific uses.

Is Pain Relieving a controlled substance?

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

What is the generic name for Pain Relieving?

The generic name for Pain Relieving is Menthol, Camphor, Capsaicin. There are 1 other brand versions of Menthol, Camphor, Capsaicin.

What is the NDC code for Pain Relieving 3.85 g/100mL?

The NDC (National Drug Code) for Pain Relieving 3.85 g/100mL is 68678-039, listed by AHC VENTURES CORP DBA CRY.

Product NDC

68678-039

Package NDC

68678-039-04

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)