BERRI-FREEZ- menthol gel

Berri-Freez by

Drug Labeling and Warnings

Berri-Freez by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Keep away from heat and open flame

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children if swallowed, get medical

attention or contact the poison control center immediately

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BERRI-FREEZ 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.085 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER 940 (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THYME (UNII: CW657OBU4N)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-009-04	113 g in 1 TUBE; Type 0: Not a Combination Product	07/31/2015
2	NDC: 54162-009-16	454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/31/2015

Labeler - Geritrex LLC (112796248)

Registrant - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-009)