FREDS ANTISEPTIC INSTANT PAIN RELIEF- camphor 10.8% and phenol 4.7% liquid

Freds Antiseptic Instant Pain Relief by

Drug Labeling and Warnings

Freds Antiseptic Instant Pain Relief by is a Otc medication manufactured, distributed, or labeled by Fred's, Inc, Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Camphor 10.8%, Phenol 4.7 %

Purpose

Pain Reliever, Antiseptic

Uses:

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

Warnings:

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:

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

Stop use and consult a doctor if:

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.

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

Directions:

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:

Citric acid, Eucalyptus Oil, Light Mineral Oil

Label

INGREDIENTS AND APPEARANCE

FREDS ANTISEPTIC INSTANT PAIN RELIEF 
camphor 10.8% and phenol 4.7% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	108 mg  in 1 mL
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	47 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-050-05	45 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/09/2017	11/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/09/2017	11/30/2020

Labeler - Fred's, Inc (005866116)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	label(55315-050) , manufacture(55315-050) , pack(55315-050) , analysis(55315-050)