PAIN RELIEVING ROLL-ON- menthol, camphor, capsaicin lotion 
AHC VENTURES CORP DBA CRY

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.

----------

Cryoderm Heat Warming Roll On

Warnings:

For external use only

Purpose

Pain Reliever

Other Information

Store in a cool dry place with lid or cap closed tightly.
Flammable: Keep away from excessive heat or open flame

Active Ingredient

Menthol USP 3.85%

Camphor USP 3.85%

Capsaicin USP 0.0355%

Directions

Adults and children 2 years and older:
Apply a small amount directly on the skin over the affected 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

Keep Out of Reach of Children

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

Inactive Ingredients

Aloe Vera, Arnica Extract, Boswellia Serrata Extract, Green Tea Extract, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Orange Fruit Extract, Grapefruit Extract, Dimethyl Sulfone, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis Leaf Extract, Phenoxyethanol, Purified Water, Rose Extract, Vitamin E, Triethanolamine, Yucca Extract

Uses

Temporary relieves minor aches and pains associated with

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 a doctor if:

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

If Pregnant or Breast Feeding:

Ask a health professional before use

This product contains Capsaicin

and may cause temporary burning, stinging, inflammation, redness or welts on the application site thatususally disappear in a few days. If you experience any of these symptoms discontinue use and contact your doctor immediately

PDP

CryoDerm

HEAT

PAIN RELIEVING

WARMING Therapy

ROLL-ON

Fast, Deep Penetrating Pain Relief for:

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

Paraben Free / Propylene Glycol Free / Aspirin Free
NSAID Free / Silicone Dioxide Free / Gluten Free

Contains Essential Oils & Natural Extracts

MSM Arnica Boswellia Ilex


Active Ingredients:
Menthol . Camphor . Capsaicin

3 fl.oz. 84mL

Cryoderm Heat Roll on

PAIN RELIEVING ROLL-ON 
menthol, camphor, capsaicin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68678-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.85 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.85 g  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0355 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 77.3645 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 100 mL
ARNICA MONTANA (UNII: O80TY208ZW) 0.5 mL  in 100 mL
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ) 0.5 mL  in 100 mL
GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1 mL  in 100 mL
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) 1 mL  in 100 mL
CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O) 0.5 mL  in 100 mL
GRAPEFRUIT (UNII: O82C39RR8C) 0.5 mL  in 100 mL
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) 3.5 mL  in 100 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) 0.5 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.7 mL  in 100 mL
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q) 0.5 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.5 mL  in 100 mL
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC) 0.5 mL  in 100 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68678-040-9084 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2016
Labeler - AHC VENTURES CORP DBA CRY (131871779)

Revised: 4/2022
Document Id: dd08fbf6-8020-ce1d-e053-2a95a90aa072
Set id: 799751f3-726a-42de-934e-dbc3cd1cb8b8
Version: 3
Effective Time: 20220419
 
AHC VENTURES CORP DBA CRY