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NDC 54633-0414-03 K2 Cold Therapy 10 g/100mL Details

K2 Cold Therapy 10 g/100mL

K2 Cold Therapy is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by The Podiatree Co. The primary component is MENTHOL.

Product Information

NDC	54633-0414
Product ID	54633-414_625ba6c8-a04b-12c9-e053-2991aa0aad86
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	K2 Cold Therapy
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	g/100mL
Substance Name	MENTHOL
Labeler Name	The Podiatree Co
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 54633-0414-03 (54633041403)

Pricing Information	N/A
NDC Package Code	54633-414-03
Billing NDC	54633041403
Package	88.72 mL in 1 BOTTLE, WITH APPLICATOR (54633-414-03)
Marketing Start Date	2014-05-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60dce1ad-125e-396d-e053-2a91aa0a670f Details

Active ingredient:

Menthol 10%

Purpose

Topical Analgesic

Uses

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

ARTHRITIS
SIMPLE BACKACHE
MUSCLE STRAINS
SPRAINS

Warnings

For external use only.

When using this product

Use only as directed
Do not bandage tighlty or use with a heating pad
Avoid contact with eyes and mucous membranes
Do not apply to wounds or damaged, broken, or irritated skin.

Stop use and ask a doctor if

Condition worsens
Redness is present
Irritation develops
Symptoms persist for more than 7 days or clear up and reoccur within a few days

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: Apply a thin layer over the affected area not more than 3 to 4 times daily.
Children 12 years of age or younger: Consult a doctor.
Close cap tightly after use.

Other information

Store at controlled room temperature. Do not shake bottle with cap removed.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Camphor, Eucalyptus Globulus Leaf Oil, FD&C Blue #1, FD&C Yellow #5, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Oil, SD 40 Alcohol (5%) Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Sesquioleate, Steareth 2, Steareth 20, Urea, Vitis Vinifera (Grape) Seed Extract, Water (Purified)

Questions or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisf ication. If you are not completely satisfied, please contact us for a full refund.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

K2 COLD THERAPY

menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54633-414
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
ALCOHOL (UNII: 3K9958V90M)
SIMMONDSIA CHINENSIS WHOLE (UNII: DFM16KFA82)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
UREA (UNII: 8W8T17847W)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54633-414-03	88.72 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/06/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/06/2014

Labeler - The Podiatree Co (078656000)

Revised: 1/2018

Document Id: 625ba6c8-a04b-12c9-e053-2991aa0aad86

Set id: 60dce1ad-125e-396d-e053-2a91aa0a670f

Version: 3

Effective Time: 20180109