BERRI-FREEZ- menthol gel 
Preferred Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Berri-Freez

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

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

Berry Freez
BERRI-FREEZ 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9553(NDC:54162-009)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9553-1113 g in 1 TUBE; Type 0: Not a Combination Product10/07/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/07/201306/19/2019
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-9553)

Revised: 6/2019
 
Preferred Pharmaceuticals, Inc.