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NDC 68678-0051-38 Pain Relieving Cold Therapy 10 g/100L Details

Pain Relieving Cold Therapy 10 g/100L

Pain Relieving 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	68678-0051
Product ID	68678-051_de20f3ae-5d78-fa08-e053-2995a90a615c
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	Pain Relieving 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/100L
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 68678-0051-38 (68678005138)

Pricing Information	N/A
NDC Package Code	68678-051-38
Billing NDC	68678005138
Package	4.2 L in 1 BOTTLE, DISPENSING (68678-051-38)
Marketing Start Date	2016-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL de210c3a-c24e-cefd-e053-2a95a90a93ff Details

Active Ingredient

Menthol USP 10.0%

Purpose

Pain Reliever

Uses

Temporarily relieves minor minor aches and pains associated with

sore musclkes and joints
arthritis
backache
muscle strains
sprains
bruises

Warnings

For external use only

When using this product

Use only as directed

Do not bandage or cover the area being treated

Do not apply ice or heating pad in conjunction with this product

Do not use with any medical device or any other device

Do not combine with any other topical treatments

Avoid contact with eyes or mucous membrane

Do not apply to wounds or damaged skin

Stop use and ask a doctor if:

Conditions worsens or symptoms persist for more than 7 days or clear up and recur

Redness if present or irritation develops

If Pregnant or Breast Feeding

Ask a healthcare professional before use

Keep Out of Reach of Children

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

Directions - Adults and children 2 years of age and older

Massage a liberal amount of gel directly on the skin over the affected area

Repeat as necessary but do not apply more than 4 times daily

Children under 2 years of age: Consult a physician

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, Boswella Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone(MSM), Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine

PDP

CryoDerm

Pain Relieving Cold Therapy

Gel

Fast Acting, Penetrating Pain Relief For:

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

Contains Essential Oils and Natural Extracts

MSM Arnica Boswellia Ilex

Active Ingredient: Menthol

1 Gallon 128 fl. oz 4.2L

INGREDIENTS AND APPEARANCE

PAIN RELIEVING COLD THERAPY

menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68678-051
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 L

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PEPPERMINT OIL (UNII: AV092KU4JH)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
EUCALYPTUS OIL (UNII: 2R04ONI662)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TROLAMINE (UNII: 9O3K93S3TK)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68678-051-38	4.2 L 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)

Revised: 5/2022

Document Id: de20f3ae-5d78-fa08-e053-2995a90a615c

Set id: de210c3a-c24e-cefd-e053-2a95a90a93ff

Version: 1

Effective Time: 20220503