PAIN RELIEVING ROLL-ON- menthol, camphor, capsaicin lotion

Pain Relieving Roll-On by

Drug Labeling and Warnings

Pain Relieving Roll-On by is a Otc medication manufactured, distributed, or labeled by AHC VENTURES CORP DBA CRY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings:

For external use only

DOSAGE & ADMINISTRATION

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

• sore muscles and joints
• arthritis
• backache
• muscle strains
• sprains
• bruises

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 ROLL-ON

with
Menthol . Camphor . Capsaicin
And Essential Oils & Natural Extracts

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

Fast, Deep Penetrating Pain Relief for:
Muscle Strains, Joint Pain, Backache, Arthritis,
Sprained Ligaments & Bruises

Pain Relieving Lotion . Greaseless . No-Mess . Non-Staining

3 fl.oz. 84mL

INGREDIENTS AND APPEARANCE

PAIN RELIEVING ROLL-ON 
menthol, camphor, capsaicin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68678-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.85 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)	CAPSAICIN	0.0355 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68678-040-90	84 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/01/2016

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

Labeler - AHC VENTURES CORP DBA CRY (131871779)