BIOFREEZE- menthol spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Performance Health LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporary relief from minor aches and pains of sore muscles and joints associated with: -arthritis - backache - strains - sprains
Authorization status:
OTC monograph not final
Authorization number:
59316-104-10, 59316-104-20, 59316-104-25, 59316-104-30

BIOFREEZE- menthol spray

Performance Health LLC

Reference Label Set Id: 44348c53-b600-4189-a797-379523b87480

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.

----------

Biofreeze Pain Relieving Spray

Drug Facts

Active Ingredients:

Menthol USP 10%

Purpose

Cooling Pain Reliever

Us es :

Temporary relief from minor aches and pains of sore muscles and joints associated with: -arthritis -

backache - strains - sprains

Warnings :

For external use only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have:

sensitive skin

When Using This Product:

-Avoid contact with the eyes or mucous membranes - Do not apply to wounds or damages skin -Do not

use with other ointments, creams, sprays or liniments -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 And Ask A Doctor If:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

If pregnant or breastfeeding:

Ask a health professional before use.

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

Adults / Children 12 years and older: Apply on to affected area up to 4 times daily

Children under 12 years of age: Consult a physician

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone (MSM), Echinacea, Ethanol, Lex

Paraguarenis, Isopropyl Myristate, Juniper Berry, Purified Water USP, White Tea

Questions or Comments?

1-800-246-3733

BIOFREEZE - menthol spray (59316-104-10)

BIOFREEZE - menthol spray (59316-104-30)

59316-104-25 Package Label

BIOFREEZE

menthol spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 316 -10 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

10 0 mg in 1 mL

Performance Health LLC

Inactive Ingredients

Ingredient Name

Stre ng th

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

CHAMO MILE (UNII: FGL36 8 5T2X)

DIMETHYL SULFO XIDE (UNII: YOW8 V9 6 9 8 H)

ECHINACEA, UNSPECIFIED (UNII: 4N9 P6 CC1DX)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ILEX PARAGUARIENSIS LEAF (UNII: 1Q9 53B4O4F)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

JUNIPERUS CO MMUNIS WHO LE (UNII: 46 49 10 T5N9 )

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:59 316 -10 4-

59 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /25/20 16

2

NDC:59 316 -10 4-

118 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /25/20 16

3

NDC:59 316 -10 4-

473 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /25/20 16

4

NDC:59 316 -10 4-

118 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/29 /20 12

12/31/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

11/0 1/20 10

Labeler -

Performance Health LLC (794324061)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Span Packaging Services LLC dba Multi-Pack So lutio ns

11710 1131

ma nufa c ture (59 316 -10 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Span Packaging services LLC

5574348 0 5

ma nufa c ture (59 316 -10 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co smetic Essence, LLC.

8 256 46 8 6 2

ma nufa c ture (59 316 -10 4)

Revised: 4/2020

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