BERRI-FREEZ- menthol spray

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]

ACTIVE INGREDIENT

Active Ingredient:    

Menthol USP 10%

Purpose:

Cooling Pain Reliever

Uses:

Temporary relief of minor aches and pains related to:

• Back, Shoulder, and Neck strains
• Ankle, Knee, Hip and Elbow joint discomfort
• Muscle sprains and strains
• Arthritis

Warnings:

For external use only. Keep out of reach of children.

WARNINGS

Flammable: Keep away from excessive heat or open flame. If accidnetally ingested, get medical help or contact a Poison Control Center immediately.

When using this Product:

Avoid contact with the eyes or mucous membranes

Do not apply to wounds or damaged skin

Do not apply to irritated skin or if excessive irritation develops

Do not bandage

Wash hands after use with cool water

Do not use with heating pad or device

STOP USE

Stop Use and ask a Doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up or reoccur

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding ask a health professional before use.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older:
1-2 sprays on the affected areas as needed but not more than 4 times daily; massage not necessary.

Inactive Ingredients:

Arnica Montana, Calendula, Chamomile, Echinacea, Ethanol, ILEX Paragurenis, Isopropyl Myristate, Juniper Berry, Water, White Tea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BERRI-FREEZ 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	11.8 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA (UNII: O80TY208ZW)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
CHAMOMILE (UNII: FGL3685T2X)
WHITE TEA (UNII: O0M3396E09)
ALCOHOL (UNII: 3K9958V90M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
JUNIPER BERRY (UNII: O84B5194RL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-002-04	118 mL in 1 BOTTLE, SPRAY; 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)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-002)