OTC Medication Information: LID O CREME ROLL ON

LID O CREME ROLL ON- menthol and lidocaine hydrochloride cream
Pharma Natural, Inc.

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.

DRUG FACTS

Active ingredients and Purpose

Active ingredients	Purpose
Lidocaine HCL 4%……………………….	Topical analgesic
Menthol 1%…………………………………	Topical analgesic

Use

For the temporary relief of pain.

Warnings

For external use only. Avoid contact with the eyes.

Do not use

in large quantities, particularly over raw surfaces, or blistered areas.

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

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

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

▪ store in a cool dry place between (59-86°F)15-30°C

▪ don’t use if seal over cap is broken, torn, or missing

Inactive ingredients

aloe vera leaf, alpha-tocopherol, arnica montana flower, caprylhydroxamic acid, caprylyl glycol, cyclomethicone 5, dimethicone, dimethyl sulfone, glycerin, glyceryl monostearate, glycol stearate, methylpropanediol, PEG-100 stearate, PEG/PPG-18/18-dimethicone, phenoxyethanol, sodium lauryl sulfate, sodium polyacrylate, stearyl alcohol, sweet almond oil, trideceth-6, water

Questions or comments?

+1-305-231-8977 (M-F) 9 A.M. — 5 P.M. EST or www.pharmanatural.com

Manufactured & Distributed by:

Pharma Natural, Inc.

Hialeah, FL 33016

Principal Display Panel

PAIN RELIEVING

Pharma Natural

Natural Health Solutions

Lid O Creme

Maximum Strength

Topical Analgesic Cream

Roll-On

LIDOCAINE HCL 4%

MENTHOL 1%

2.5 oz. (71 g)

LID O CREME ROLL ON lidocaine hcl, menthol cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63788-111 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 1 g in 100 g LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g

Inactive Ingredients Ingredient Name Strength ARNICA MONTANA FLOWER CAPRYLHYDROXAMIC ACID SODIUM LAURYL SULFATE SODIUM POLYACRYLATE (8000 MW) TRIDECETH-6 WATER ALOE VERA LEAF ALPHA-TOCOPHEROL DIMETHYL SULFONE GLYCERIN GLYCERYL MONOSTEARATE DIMETHICONE GLYCOL STEARATE METHYLPROPANEDIOL ALMOND OIL PHENOXYETHANOL PEG-100 STEARATE PEG/PPG-18/18 DIMETHICONE CAPRYLYL GLYCOL CYCLOMETHICONE 5 STEARYL ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63788-111-25 71 g in 1 BOTTLE, WITH APPLICATOR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2018

Labeler — Pharma Natural, Inc. (138059287)

Revised: 08/2018 Pharma Natural, Inc.