Berri-Freez description, usages, side effects, indications, overdosage, supplying and lots more!

Berri-Freez

Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Berri-Freez

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient Purpose

Menthol USP 4.5% Pain Relieving Gel

Uses

For the temporary relief of minor aches and

pains of muscles and joints associated with simple

backache, arthritis, strains, bruises, and sprains

Directions

For adults or children 2 years of age and older

Children under 2 years of age, consult a doctor

Cleanse and dry skin

Apply to affected area not more than 3 to 4 times daily

May be used with wet or dry bandages in conjunction with ice packs

Keep container tightly closed

Apply to affected area not more than 3 to 4 times daily

Warnings

For External Use Only Use only as directed

Avoid contact with the eyes. Do not bandage tightly

Do not apply to wounds or damaged skin

Do not use with a heating pad

Stop use and ask a doctor if condition worsens or if

symptoms persist for more than 7 days or clear up

and occur again within a few days

Inactive Ingredients

Camphor, Carbomer 940, FD&C Blue#1, FD&C Yellow#5

DMDM Hydantoin, Glycerine, I.paraguariensis Extract, Isopropyl Alcohol

Methyl & Propyle paraben, Silicon Dioxide, Thyme, Triethanolamine, water

4 oz - 68788-9553-1

Keep away from heat and open flame

Store at room temperature 15'-30'C (59'-86'F)

Keep out of reach of children if swallowed, get medical

attention or contact the poison control center immediately

Relabeled by Preferred Pharmaceuticals, Inc.

Berri-Freez

MENTHOL GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-9553(NDC:54162-009)
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 4.5 g

Inactive Ingredients

Ingredient Name Strength
CAMPHOR (SYNTHETIC)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
DMDM HYDANTOIN
GLYCERIN
ILEX PARAGUARIENSIS LEAF
ISOPROPYL ALCOHOL
METHYLPARABEN
PROPYLPARABEN
SILICON DIOXIDE
THYME
TROLAMINE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68788-9553-1 113 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-10-07


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