FDA.reportPublic FDA data

Freds Antiseptic Instant Pain Relief

Manufacturer
Fred's, Inc | Humco Holding Group, Inc.
Effective date
2020-02-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:40:27

Label at a glance#

ProductFreds Antiseptic Instant Pain Relief
Active ingredientCAMPHOR (NATURAL), PHENOL
Label structure11 sections

Indications and uses

Helps prevent infection and temporarily relieves pain and itching in minor burns, cuts, insect bites, scrapes, sunburn and other minor skin irritations.

Dosage and administration

Adult and children 2 yrs and older: apply to affected area 1 to 3 times daily. Children under 2 yrs of age: Consult a doctor before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 10.8%, Phenol 4.7 %

Purpose

OTC - PURPOSE SECTION

Pain Reliever, Antiseptic

Uses:

INDICATIONS & USAGE SECTION

Helps prevent infection and temporarily relieves pain and itching in minor burns, cuts, insect bites, scrapes, sunburn and other minor skin irritations.

Warnings:

WARNINGS SECTION

For External Use Only. Do not induce vomiting. If vomiting occurs give fluids again. Do not use in or near the eyes: In case of eye contact, flush eyes with running water for 15 minutes, get medical attention immediately. Do not use on: deep punture wounds, animal bites, serious burns.

When using this product:

OTC - WHEN USING SECTION

Do not bandage. Do not use over large areas of the body.

Stop use and consult a doctor if:

OTC - STOP USE SECTION

Condition worsens. Symptoms last more than 7 days or clear up and occur again in a few days.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adult and children 2 yrs and older: apply to affected area 1 to 3 times daily.

Children under 2 yrs of age: Consult a doctor before use.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Citric acid, Eucalyptus Oil, Light Mineral Oil

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-05055315-050-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662IACT
LIGHT MINERAL OILN6K5787QVPIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
PHENOL339NCG44TVACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9f07c2f5-160b-76e1-e053-2995a90a4eba5df44683-ad2c-7fd4-e053-2991aa0ac1402020-02-20WarningsExact identifier
spl id: 9f07c2f5-160b-76e1-e053-2995a90a4eba
spl set id: 5df44683-ad2c-7fd4-e053-2991aa0ac140

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.