PARAID EXTRA STRENGTH MENTHOL PAIN RELIEF SLEEVE KNEE LARGE ANKLES ELBOWS- menthol lotion 
Planet (Suzhou) Medical Products Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PARAID Extra Strength Menthol Pain Relief Sleeve KNEE & Large Ankles & Elbows

Active Ingredient

Menthol 16.0%

Purpose

Topical Analgesic Patch

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

- arthritis - strains - bruises - sprains

Warnings

For external use only

When using this product

- avoid contact with eyes

- do not apply to wounds or damaged skin

- do not bandage tightly

- do not use with heating pad

Stop using and ask a doctor

if redness is present or irritation develops. Condition worsens, or if symptoms persist for 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 immediately.

Directions

- Adults and children over 12 years: pull sleeve onto knee or large ankles or elbows untill the colored section of the sleeve is positioned directly over the affected area. Sleeve should feel snug but not tight.
- Children 12 years or younger: consult a doctor.

Inactive ingredients

diethylene glycol monoethyl ether acetate, cetanol, glycerol, glycerol monostearate, methylparaben, 2(2-aminoethoxy) ethanol, sorbitan sesquiolate, sodium polyacrylate, polysorbate 80, aloe barbadensis leaf extract, methyl orange- xylene cyanol solution, ethylenediaminetetracetic acid tetrasodium salt hydrate

PARAID Extra Strength Menthol Pain Relief Sleeve KNEE & Large Ankles & Elbows (50076-300-01)

Extra Strength         Menthol 16%

PARAID

Menthol

Pain Relief Sleeve

Knee & Large Ankles & Elbows

Medicated Sleeve

Pain Relieving Lotion on a Breatable Sleeve

LARGE SLEEVE

Ideal for KNEE

EXPANDS TO FIT 8" TO 24" IN CIRCUMFERENCE

Contains 1 Sleeve Patch

Kneesleeve

PARAID EXTRA STRENGTH MENTHOL PAIN RELIEF SLEEVE KNEE LARGE ANKLES ELBOWS 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50076-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYL ORANGE (UNII: 6B4TC34456)  
EDETIC ACID (UNII: 9G34HU7RV0)  
SOLASULFONE (UNII: H12JE4313S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50076-300-001 in 1 BOX09/29/201409/29/2014
15 mL in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/29/201409/29/2014
Labeler - Planet (Suzhou) Medical Products Co., Ltd. (528194366)

Revised: 5/2017
 
Planet (Suzhou) Medical Products Co., Ltd.