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NDC 37205-0824-26 Pain Relieving 35 mg/mL Details

Pain Relieving 35 mg/mL

Pain Relieving is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	37205-0824
Product ID	37205-824_93f93142-2b32-4589-904d-48290c2622e0
Associated GPIs	90070060004017
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
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	35
Active Ingredient Units	mg/mL
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	Cardinal Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	n/a

Package

Package Images

NDC 37205-0824-26 (37205082426)

Pricing Information	N/A
NDC Package Code	37205-824-26
Billing NDC	37205082426
Package	1 BOTTLE in 1 CARTON (37205-824-26) / 118 mL in 1 BOTTLE
Marketing Start Date	2012-01-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fcb2335a-497e-4c3e-bd75-780e9634f249 Details

Drug Facts

Active Ingredients

Active Ingredients

Menthol 3.5%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with • arthritis • backache • strains • sprains

Warnings:

For external use only

Ask a doctor before use if you have:

sensitive skin, are pregnant or breast feeding

When Using This Product:

• Avoid contact with eyes or mucous membranes

• Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops

• Do not bandage or use with heating pad or device. ointments, creams, sprays. liniments

• Wash hands after with cool water

Stop Use And Ask A Doctor If:

Condition worsens. symptoms persist more than 7 days, or clear up and recur

Keep out of reach of children:

If ingested, get medical help. Contact Poison Control Center immediately.

Directions:

• Adults / Children 2 years and older: Massage onto affected area up to 4 times daily. • Children under 2 years of age: Consult physician

Other Information:

Store in cool dry place, lid closed tightly. keep away from excessive heat or open flame.

Inactive Ingredients:

Water, isopropyl alcohol, herbal extract (IIex paraguariensis), menthol, carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FDandC blue #1

Package Labeling:

INGREDIENTS AND APPEARANCE

PAIN RELIEVING

menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-824
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	35 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-824-26	1 in 1 CARTON	01/18/2012	12/31/2024
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/18/2012	12/31/2024

Labeler - Cardinal Health (097537435)

Name	Address	ID/FEI	Business Operations
Establishment
Span Packaging Services LLC		117101131	manufacture(37205-824)

Name	Address	ID/FEI	Business Operations
Establishment
Span Packaging Services LLC		557434805	manufacture(37205-824)

Revised: 12/2021

Document Id: 93f93142-2b32-4589-904d-48290c2622e0

Set id: fcb2335a-497e-4c3e-bd75-780e9634f249

Version: 6

Effective Time: 20211222