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NDC 68678-0039-04 Pain Relieving 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL Details

Pain Relieving 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL

Pain Relieving 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	68678-0039
Product ID	68678-039_de9b5859-544a-1d2d-e053-2a95a90a844d
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
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 68678-0039-04 (68678003904)

Pricing Information	N/A
NDC Package Code	68678-039-04
Billing NDC	68678003904
Package	112 mL in 1 BOTTLE, DISPENSING (68678-039-04)
Marketing Start Date	2016-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 27679d31-a5f3-417b-b0c5-5f6b001ecff9 Details

Directions

Adults and children 2 years and older:

Massage a small amount of lotion 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

Active Ingredient

Menthol USP 3.85%

Camphor USP 3.85%

Capsaicin USP 0.0355%

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

Other Information

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

Flammable: Keep away from excessive heat or open flame

Keep Out of Reach of Children

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

Purpose

Pain Reliever

Uses

Temporary relieves minor aches and pains associated with

sore muscles and joints
arthritis
backache
muscle strains
sprains
bruises

SPL UNCLASSIFIED SECTION

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 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

PRINCIPAL DISPLAY PANEL

CryoDerm

HEAT

PAIN RELIEVING

WARM Therapy

Lotion

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

16 fl.oz. 449mL

INGREDIENTS AND APPEARANCE

PAIN RELIEVING

menthol, camphor, capsaicin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68678-039
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, DL- (UNII: WR1WPI7EW8)	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
Packaging
1	NDC:68678-039-16	449 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/01/2016
2	NDC:68678-039-04	112 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/01/2016
3	NDC:68678-039-99	3.35 mL in 1 PACKET; 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: 5/2022

Document Id: de9b5859-544a-1d2d-e053-2a95a90a844d

Set id: 27679d31-a5f3-417b-b0c5-5f6b001ecff9

Version: 4

Effective Time: 20220509

Search by Drug Name or NDC

NDC 68678-0039-04 Pain Relieving 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL Details

Pain Relieving 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL

Product Information

Package

Package Images

NDC 68678-0039-04 (68678003904)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 27679d31-a5f3-417b-b0c5-5f6b001ecff9 Details

Directions

Active Ingredient

Inactive Ingredients

Other Information

Keep Out of Reach of Children

Purpose

Uses

SPL UNCLASSIFIED SECTION

Warnings

When using this product:

Stop use and ask a doctor if:

If pregnant or Breast Feeding:

this product contains Capsaicin

PRINCIPAL DISPLAY PANEL

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 68678-0039-04 Pain Relieving 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL Details

Pain Relieving 3.85; .0355; 3.85 g/100mL; g/100mL; g/100mL

Product Information

Package

Package Images

NDC 68678-0039-04 (68678003904)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 27679d31-a5f3-417b-b0c5-5f6b001ecff9 Details

﻿Directions

﻿Active Ingredient

﻿Inactive Ingredients

﻿Other Information

﻿Keep Out of Reach of Children

﻿Purpose

﻿Uses

SPL UNCLASSIFIED SECTION

﻿Warnings

﻿When using this product:

﻿Stop use and ask a doctor if:

﻿If pregnant or Breast Feeding:

this product contains Capsaicin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Directions

Active Ingredient

Inactive Ingredients

Other Information

Keep Out of Reach of Children

Purpose

Uses

Warnings

When using this product:

Stop use and ask a doctor if:

If pregnant or Breast Feeding: