LID O CREME ROLL ON- lidocaine hcl, menthol 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.

----------

LID O CREME

DRUG FACTS

Active ingredients and Purpose

Active ingredientsPurpose
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)

LIDOCREME_LABEL

LID O CREME ROLL ON 
lidocaine hcl, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63788-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
ALMOND OIL (UNII: 66YXD4DKO9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63788-111-2571 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2018
Labeler - Pharma Natural, Inc. (138059287)

Revised: 8/2018
Document Id: 74c598b4-ef73-b4fa-e053-2991aa0a223a
Set id: 6fca06cb-fda0-e36c-e053-2991aa0ad6a8
Version: 2
Effective Time: 20180831
 
Pharma Natural, Inc.