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NDC 68001-0479-45 Pain Relieving 10; 15 g/100g; g/100g Details

Pain Relieving 10; 15 g/100g; g/100g

Pain Relieving is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by BluePoint Laboratories. The primary component is MENTHOL; METHYL SALICYLATE.

Product Information

NDC	68001-0479
Product ID	68001-479_dc73db77-ab4a-49fa-e053-2995a90ae501
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	Pain Relieving
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10; 15
Active Ingredient Units	g/100g; g/100g
Substance Name	MENTHOL; METHYL SALICYLATE
Labeler Name	BluePoint Laboratories
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 68001-0479-45 (68001047945)

Pricing Information	N/A
NDC Package Code	68001-479-45
Billing NDC	68001047945
Package	1 TUBE in 1 CARTON (68001-479-45) / 85.05 g in 1 TUBE
Marketing Start Date	2022-05-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dc73db77-ab49-49fa-e053-2995a90ae501 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

Menthol 10%

Methyl Salicylate 15%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only

Do not use on

wounds or damaged skin

When using this product

avoid contact with eyes
do not bandage tightly

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: Consult a doctor

Other Information

Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
Store at room temperature
See Crimp of tube or carton for Lot Number and Expiry Date

Inactive ingredients

Allantoin, Carbopol Ultrez 10, Cetyl Alcohol, Dimethicone 350, Edetate Disodium, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methyl Paraben, Phenoxyethanol, Potassium Cetyl Phosphate, Propyl Paraben, Purified Water, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Tween 20, Vitamin E, Xanthan Gum

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited

Plot No. A327, T.T.C Indl. Area, M.I.D.C

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/739

For BluePoint Laboratories

Rev 04/2022

Package Label - Principal Display Panel

Non-Greasy Pain Relieving (Muscle Rub) (Tube)

NDC: 68001-479-45

Non-Greasy Pain Relieving (Muscle Rub) (Carton)