BERRI-FREEZ PLUS- menthol, camphor, methyl salicylate gel

Berri-Freez Plus by

Drug Labeling and Warnings

Berri-Freez Plus 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

Methyl Salicylate 8%        Pain Relief

Menthol USP 4%              Pain Relief
Camphor USP 0.2%         Pain Relief

Uses

For the temporary relief of minor aches and
pains of muscles and joints associated with simple
backache, arthritis, strains, bruises, and sprains.

WARNINGS

• For External Use Only
• Use only as directed
• Avoid contact with eyes
• Do not bandage tightly
• Do not apply to wounds or damaged skin
• Do not use with heating pad

STOP USE

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical attention or contact the Poison Control Center immediately.

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

• For adults & 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 

STORAGE AND HANDLING

• Keep container tightly closed
• Keep away from heat and open flame
• Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredient

Aloe, Arnica, Calendula, Carbomers, FD&C Blue #1, FD&C Yellow #5, DMDM Hydantoin, Glycerine, Green Tea, L. Paraguariensis, Isopropyl Alcohol, Methyl & Propyl Paraben, PEG-40, Hydrogenated Castor Oil, Silicone Dioxide, Tea Tree Oil, Thyme, Triethanolamine, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BERRI-FREEZ PLUS 
menthol, camphor, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.52 g  in 113 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.226 g  in 113 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	9.04 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)
CALENDULA ARVENSIS LEAF (UNII: 3U3U118F2L)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
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)
THYME (UNII: CW657OBU4N)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-008-04	113 g in 1 TUBE; Type 0: Not a Combination Product

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)