Search by Drug Name or NDC

NDC 68678-0040-90 Pain Relieving Roll-On 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL Details

Pain Relieving Roll-On 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL

Pain Relieving Roll-On is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by AHC VENTURES CORP DBA CRY. The primary component is CAMPHOR (SYNTHETIC); CAPSAICIN; MENTHOL.

Product Information

NDC	68678-0040
Product ID	68678-040_dd08fbf6-8020-ce1d-e053-2a95a90aa072
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 Roll-On
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol, Camphor, Capsaicin
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	3.85; .0355; 3.85
Active Ingredient Units	g/100mL; g/100mL; g/100mL
Substance Name	CAMPHOR (SYNTHETIC); CAPSAICIN; MENTHOL
Labeler Name	AHC VENTURES CORP DBA CRY
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 68678-0040-90 (68678004090)

Pricing Information	N/A
NDC Package Code	68678-040-90
Billing NDC	68678004090
Package	84 mL in 1 BOTTLE, DISPENSING (68678-040-90)
Marketing Start Date	2016-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 799751f3-726a-42de-934e-dbc3cd1cb8b8 Details

Warnings:

For external use only

SPL UNCLASSIFIED SECTION

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 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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68678-040-90	84 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 CRY (131871779)

Revised: 4/2022

Document Id: dd08fbf6-8020-ce1d-e053-2a95a90aa072

Set id: 799751f3-726a-42de-934e-dbc3cd1cb8b8

Version: 3

Effective Time: 20220419

Search by Drug Name or NDC

NDC 68678-0040-90 Pain Relieving Roll-On 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL Details

Pain Relieving Roll-On 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL

Product Information

Package

Package Images

NDC 68678-0040-90 (68678004090)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 799751f3-726a-42de-934e-dbc3cd1cb8b8 Details

Warnings:

SPL UNCLASSIFIED SECTION

Purpose

Other Information

Active Ingredient

Directions

Keep Out of Reach of Children

Inactive Ingredients

Uses

When using this product:

Stop use and ask a doctor if:

If Pregnant or Breast Feeding:

This product contains Capsaicin

PDP

INGREDIENTS AND APPEARANCE

Question Regarding Timing of Multiple Propranolol Doses

Can You Take A Z-Pak If You Have A Penicillin Allergy?

Search by Drug Name or NDC

NDC 68678-0040-90 Pain Relieving Roll-On 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL Details

Pain Relieving Roll-On 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL

Product Information

Package

Package Images

NDC 68678-0040-90 (68678004090)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 799751f3-726a-42de-934e-dbc3cd1cb8b8 Details

﻿Warnings:

SPL UNCLASSIFIED SECTION

Purpose

﻿Other Information

﻿Active Ingredient

﻿Directions

﻿Keep Out of Reach of Children

Inactive Ingredients

﻿Uses

﻿When using this product:

﻿Stop use and ask a doctor if:

﻿If Pregnant or Breast Feeding:

﻿This product contains Capsaicin

PDP

INGREDIENTS AND APPEARANCE

Warnings:

Other Information

Active Ingredient

Directions

Keep Out of Reach of Children

Uses

When using this product:

Stop use and ask a doctor if:

If Pregnant or Breast Feeding:

This product contains Capsaicin