LID O CREME ROLL ON- lidocaine hcl, menthol cream

LID O CREME ROLL ON by

Drug Labeling and Warnings

LID O CREME ROLL ON by is a Otc medication manufactured, distributed, or labeled by Pharma Natural, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63788-111-25	71 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/01/2018

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)