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NDC 72246-0112-01 Dr. Ds Super 7 Pain Relief 20; 100 mg/mL; mg/mL Details

Dr. Ds Super 7 Pain Relief 20; 100 mg/mL; mg/mL

Dr. Ds Super 7 Pain Relief is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Promedx Innovations Inc. The primary component is MENTHOL; MENTHYL SALICYLATE, (+/-)-.

Product Information

NDC	72246-0112
Product ID	72246-112_b9e9ab5b-aff7-e8cf-e053-2995a90a93f5
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	Dr. Ds Super 7 Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	menthyl salicylate and menthol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	20; 100
Active Ingredient Units	mg/mL; mg/mL
Substance Name	MENTHOL; MENTHYL SALICYLATE, (+/-)-
Labeler Name	Promedx Innovations Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72246-0112-01 (72246011201)

Pricing Information	N/A
NDC Package Code	72246-112-01
Billing NDC	72246011201
Package	1 BOTTLE, WITH APPLICATOR in 1 CARTON (72246-112-01) / 88 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2019-09-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aaca1fbf-aed6-4fe0-9821-6fa897b5d41e Details

Drug Facts

Active Ingredient

Menthyl Salicylate 10%

Menthol 2%

Purpose

Topical analgesic

Uses

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

simple backache
arthritis
strains and sprains
bruises

Warnings

For external use only

Allergy alert

do not use if you are allergic to plants of the Asteraceae / Compositae / Daisy family

When using this product

avoid contact with the eyes and mucous membranes
do not apply to wounds or damaged skin
do not bandage tightly
do not apply with external heat, such as an electric pad, as this may result in excessive skin irritation or skin burn

Ask a healthcare professional before use if you are

taking anticoagulant medications

Stop using and ask a healthcare professional if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
if a rash develops, or you become hypersensitive and/or burning, blistering or swelling occurs, discontinue use and seek medical help immediately

If pregnant or breast-feeding

ask a healthcare professional before use

Keep out of reach of children

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

Directions

Adults and children 2 years of age and older:

shake bottle before use
apply a thin and even coat to affected area not more than 3 to 4 times daily
rub and/or massage into skin until the preparation disappears

Children (2 to 12 years old)

ask a doctor
application should be supervised by an adult

Other information

store at room temperature 15°C - 30°C (59°F - 86°F)
do not use if quality seal is missing or broken
store in airtight, light-resistant container

Inactive ingredients

Arnica Montana Flower Extract, Benzoic Acid, Brassica Campestris (Rapeseed) Seed Oil, Citric Acid, Dehydroacetic Acid, Eucalyptus Globulus Leaf Essential Oil, Glycerin, Linum Usitatissimum (Linseed) Seed Extract, MSM, Myristyl Myristate, Neopentyl Glycol Dicaprylate/Dicaprate, Peppermint Oil (Mentha piperita), Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Sodium Stearoyl Glutamate, Water, Xanthan Gum

PRINCIPAL DISPLAY PANEL

DR. D'S

SUPER 7

Enhanced Topical Pain Relief

NEW

For relief of:

Muscle, Joint

and Arthritic Pain

TRIPLE CARRIER SYSTEM

Doctor Developed
7 Powerful Natural Ingredients
Easy to Use Applicator
Paraben and PEG Free

88 mL

NDC 72246-112-01

INGREDIENTS AND APPEARANCE

DR. DS SUPER 7 PAIN RELIEF

menthyl salicylate and menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72246-112
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg in 1 mL
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ROSEMARY (UNII: IJ67X351P9)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FLAX SEED (UNII: 4110YT348C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72246-112-01	1 in 1 CARTON	09/04/2019
1		88 mL in 1 BOTTLE, WITH APPLICATOR; 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	09/04/2019

Labeler - Promedx Innovations Inc (203749853)

Revised: 1/2021

Document Id: b9e9ab5b-aff7-e8cf-e053-2995a90a93f5

Set id: aaca1fbf-aed6-4fe0-9821-6fa897b5d41e

Version: 2

Effective Time: 20210127