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NDC 59316-0101-13 Biofreeze 35 mg/mL Details

Biofreeze 35 mg/mL

Biofreeze is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	59316-0101
Product ID	59316-101_b884afb9-3926-4096-b881-e78633f4033e
Associated GPIs
GCN Sequence Number	045818
GCN Sequence Number Description	menthol/camphor GEL (GRAM) 3.5%-0.2% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	91154
HICL Sequence Number	002600
HICL Sequence Number Description	MENTHOL/CAMPHOR
Brand/Generic	Generic
Proprietary Name	Biofreeze
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	35
Active Ingredient Units	mg/mL
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59316-0101-13 (59316010113)

Pricing Information	N/A
NDC Package Code	59316-101-13
Billing NDC	59316010113
Package	59 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-13)
Marketing Start Date	2016-08-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 684faf63-5e44-4471-8384-e8fa7c0d842a Details

Active Ingredients

Menthol USP 3.5%

Purpose

Cooling Pain Reliever

Uses

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

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 damaged 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 recur.

If pregnant or breastfeeding:

Ask a health professional before use.

Keep out of the reach of children:

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

Directions

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
Children under 2 years of age : Consult physician

Other Information:

Store in a cool dry place with lid closed tightly

Inactive ingredients

carbomer, FD and C blue # 1, FD and C yellow # 5, glycerine, herbal extract (llex paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol, silicon dioxide, triethanolamine, purified water USP

Questions or Comments?

800-246-3733

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label

PENETRATING, LONG LASTING PAIN RELIEF FROM:

ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE®

PAIN RELIEVING Roll-On

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method®

3 fl oz / 89 mL

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Pump Label