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NDC 68678-0013-90 Cold Therapy 10 g/100mL Details

Cold Therapy 10 g/100mL

Cold Therapy is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by AHC VENTURES CORP DBA CRYODERM. The primary component is MENTHOL.

Product Information

NDC	68678-0013
Product ID	68678-013_dd08d57a-e9b0-3146-e053-2995a90ae940
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	Cold Therapy
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	g/100mL
Substance Name	MENTHOL
Labeler Name	AHC VENTURES CORP DBA CRYODERM
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68678-0013-90 (68678001390)

Pricing Information	N/A
NDC Package Code	68678-013-90
Billing NDC	68678001390
Package	95 mL in 1 BOTTLE, DISPENSING (68678-013-90)
Marketing Start Date	2016-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 52fff03e-eba2-4604-a71c-2522468f627b Details

SPL UNCLASSIFIED SECTION

Uses

Temporary relieves minor aches and pains associated with

sore muscles and joints
arthritis
backache
muscle strains
sprains
bruises

Active Ingredient

Menthol USP 10.0%

Purpose

Pain Reliever

Directions

Adults and children 2 years and older:

Apply directly onto afected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more than 4 times daily.

Children under 2 years of age: Consult a Physician

Warnings

For external use only

When using this product:

Use only as directed. Do not bandage or use a heating pad or device. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not use with other ointment, creams, sprays or liniments. After applying wash hands thoroughly with cool water

Stop use and ask doctor if:

Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritation develops

Keep Out of Reach of Children

In case of accidental ingestion get medical help or contact a Poison Control Center immediately

Other Information:

Store in a cool dry place with lid or cap closed tightly

Flammable: Keep away from excessive heat or open flame

Inactive Ingredients:

Acrylates, Arnica, Boswellia Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone, Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine

If Pregnant or Breast Feeding:

Consult a health professional before use

PDP

CryoDerm

Pain Relieving Cold Therapy

Roll-on

Fast Acting, Penetrating, Pain Relief For:

Muscle Strains, Joint Pain, Backache, Arthritis, Sprained Ligaments & Bruises.

Contains Essential Oils and Natural Extracts

MSM Arnica Boswellia Ilex

Active Ingredient: Menthol

3 fl. oz. 95 mL

INGREDIENTS AND APPEARANCE

COLD THERAPY

menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68678-013
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
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)	1 mL in 100 mL
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)	1 mL in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662)	0.05 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	5 mL in 100 mL
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)	1 mL in 100 mL
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)	0.03 mL in 100 mL
PEPPERMINT OIL (UNII: AV092KU4JH)	0.5 mL in 100 mL
WATER (UNII: 059QF0KO0R)	32.906 mL in 100 mL
ALCOHOL (UNII: 3K9958V90M)	48.45 mL in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.5 mL in 100 mL
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)	0.004 mL in 100 mL

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68678-013-90	95 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/01/2016

Labeler - AHC VENTURES CORP DBA CRYODERM (131871779)

Name	Address	ID/FEI	Business Operations
Establishment
Vege Labs LLC.		117878620	manufacture(68678-013)

Revised: 4/2022

Document Id: dd08d57a-e9b0-3146-e053-2995a90ae940

Set id: 52fff03e-eba2-4604-a71c-2522468f627b

Version: 3

Effective Time: 20220419

Search by Drug Name or NDC

NDC 68678-0013-90 Cold Therapy 10 g/100mL Details

Cold Therapy 10 g/100mL

Product Information

Package

Package Images

NDC 68678-0013-90 (68678001390)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 52fff03e-eba2-4604-a71c-2522468f627b Details

SPL UNCLASSIFIED SECTION

Uses

Active Ingredient

Purpose

Directions

Warnings

When using this product:

Stop use and ask doctor if:

Keep Out of Reach of Children

Other Information:

Inactive Ingredients:

If Pregnant or Breast Feeding:

PDP

INGREDIENTS AND APPEARANCE

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Search by Drug Name or NDC

NDC 68678-0013-90 Cold Therapy 10 g/100mL Details

Cold Therapy 10 g/100mL

Product Information

Package

Package Images

NDC 68678-0013-90 (68678001390)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 52fff03e-eba2-4604-a71c-2522468f627b Details

SPL UNCLASSIFIED SECTION

﻿Uses

Active Ingredient

﻿Purpose

﻿Directions

﻿Warnings

﻿When using this product:

﻿Stop use and ask doctor if:

﻿Keep Out of Reach of Children

﻿Other Information:

﻿Inactive Ingredients:

﻿If Pregnant or Breast Feeding:

PDP

INGREDIENTS AND APPEARANCE

Uses

Purpose

Directions

Warnings

When using this product:

Stop use and ask doctor if:

Keep Out of Reach of Children

Other Information:

Inactive Ingredients:

If Pregnant or Breast Feeding: