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NDC 70169-0701-01 Formula45 Arthritis Blend 100; 200 mg/g; mg/g Details

Formula45 Arthritis Blend 100; 200 mg/g; mg/g

Formula45 Arthritis Blend is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Shift Consulting Group, Inc.. The primary component is MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.

Product Information

NDC	70169-0701
Product ID	70169-701_47f4f989-fb14-6576-e054-00144ff8d46c
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	Formula45 Arthritis Blend
Proprietary Name Suffix	n/a
Non-Proprietary Name	METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	100; 200
Active Ingredient Units	mg/g; mg/g
Substance Name	MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Labeler Name	Shift Consulting Group, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70169-0701-01 (70169070101)

Pricing Information	N/A
NDC Package Code	70169-701-01
Billing NDC	70169070101
Package	1 BOTTLE in 1 CARTON (70169-701-01) / 113 g in 1 BOTTLE
Marketing Start Date	2017-02-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 29009789-6f8f-449b-a1bd-da4fad00b621 Details

Drug Facts:

Active Ingredient:

Methyl Salicylate 20.00%

Menthol 10.00%

Purpose:

Topical Analgesic

Indications:

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

simple backache
arthritis
strains
bruises
and sprains

Warnings:

For external use only

Allergy Alert: If you had prior allergic reaction to aspirin or salicylate, please consult a physician before use.

Do not use

on wounds or damaged skin
with a heating pad
children 12 years of age with arthritic conditions

Ask a physician before use if

you have redness over the affected area.

When using this product

avoid contact with eyes and mucus membranes
do not bandage highly

Stop use and ask a physician if

condition worsens or symptoms persist for more than 7 days
symptoms clearup and occur again within a few days
excessive skin irritation occurs.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions:

Use only as directed

Adults and children over 12 years of age apply to affected area not more than 3 to 4 times daily
children under 12 years of age consult a physician.

Other Ingredients:

Aqua (deionized water), arnica montana (arnica) extract, blue 1, boswellia serrata extract, C13-14 isoparaffin, cetyl alcohol, chondroitin sulfate, dimethyl sulfone (MSM), ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate, laureth-7, PEG-100 stearate, phenoxyethanol, polyacrylamide, polysorbate-20, stearic acid, yellow 5.

Package Labeling:

INGREDIENTS AND APPEARANCE

FORMULA45 ARTHRITIS BLEND

methyl salicylate, menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70169-701
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	200 mg in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-7 (UNII: Z95S6G8201)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70169-701-01	1 in 1 CARTON	02/07/2017
1		113 g 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	10/16/2015

Labeler - Shift Consulting Group, Inc. (079991681)

Revised: 2/2017

Document Id: 47f4f989-fb14-6576-e054-00144ff8d46c

Set id: 29009789-6f8f-449b-a1bd-da4fad00b621

Version: 4

Effective Time: 20170207