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NDC 71868-0080-01 Activate Joint and Muscle Relief 40; 10 mg/mL; mg/mL Details

Activate Joint and Muscle Relief 40; 10 mg/mL; mg/mL

Activate Joint and Muscle Relief is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Liberty Health Supply, LLC. The primary component is LIDOCAINE HYDROCHLORIDE; MENTHOL.

Product Information

NDC	71868-0080
Product ID	71868-080_5d58ba36-39e0-418f-e053-2a91aa0a7417
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	Activate Joint and Muscle Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	LIDOCAINE HYDROCHLORIDE, MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40; 10
Active Ingredient Units	mg/mL; mg/mL
Substance Name	LIDOCAINE HYDROCHLORIDE; MENTHOL
Labeler Name	Liberty Health Supply, LLC
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71868-0080-01 (71868008001)

Pricing Information	N/A
NDC Package Code	71868-080-01
Billing NDC	71868008001
Package	1 BOTTLE in 1 BOX (71868-080-01) / 118.294 mL in 1 BOTTLE
Marketing Start Date	2017-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 24b5b595-3ed9-47fc-8086-989a2a19142d Details

Drug Facts

Active Ingredients

4.00% Lidocaine HCl

1.00% Menthol

Purpose

Topical Anesthetic

Indications:

For the temporary relief of pain and itching due to minor burns, sunburn, minor cuts, scrapes, insect bites and minor skin irritations

Warnings:

For external use only.
Do not use in large quantities, particularly over raw or blistered areas.
If symptoms persisit for more than seven days, discontinue use and consult physician.
Avoid contact with eyes. Rinse well if contact occurs

Keep out of reach of children.

If swallowed, consult physician.

Directions:

Adults and children two-years of age or older: Apply small amount to affected area not more than three to four times daily.
Apply after shower or bath for best result
Children under two-years of age: consult a physician

Additional information:

Store at room temperature.

Other Ingredients:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Azadirachta Indica (Neem) Oil, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Calophyllum Inophyllum (Tamanu) Seed Oil, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Chondroitin Sulfate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Emu Oil, Ethylhexylglycerin, Glycerin,

Glyceryl Stearate, Glucosamine Sulfate, Laureth-7, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Sesamum

Indicum (Sesame) Seed Oil, SD-Alcohol 40B, Stearic Acid, Tocopheryl Acetate (Vitamin E), Theobroma Cacao (Cocoa) Butter, Xanthan Gum.

Package Labeling:

INGREDIENTS AND APPEARANCE

ACTIVATE JOINT AND MUSCLE RELIEF

lidocaine hydrochloride, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71868-080
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
SHEA BUTTER (UNII: K49155WL9Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
TAMANU OIL (UNII: JT3LVK84A1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BERGAMOT OIL (UNII: 39W1PKE3JI)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
LAURETH-7 (UNII: Z95S6G8201)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SESAME OIL (UNII: QX10HYY4QV)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71868-080-01	1 in 1 BOX	11/01/2017
1		118.294 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	11/01/2017

Labeler - Liberty Health Supply, LLC (080886320)

Revised: 11/2017

Document Id: 5d58ba36-39e0-418f-e053-2a91aa0a7417

Set id: 24b5b595-3ed9-47fc-8086-989a2a19142d

Version: 2

Effective Time: 20171106