DR SAYMANS WONDER RUB- lidocaine gel

Dr Saymans Wonder Rub by

Drug Labeling and Warnings

Dr Saymans Wonder Rub by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine HCL 4%

Purpose

Topical anesthetic

Uses

• Temporarily relieves minor pain

Warnings

For external use only

Do not use

• on large areas of the body or on cut,irritated or swollen skin
• on puncture wounds
• for more than one week without consultanting a doctor

When using this product

• use only as directed. Read and follow all directions and warnings on this carton.
• do not allow contact with the eyes
• do not bandage or apply local heat (such as heating pads) to the area of use.

Stop use and ask a doctor if

• condition worsens
• symptons 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 this and all drugs out of the reach of children and pets.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

• Adults and children over 12 years: 
• apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
• Children under 12 years  or younger: ask a doctor

Other information

• Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients: Alcohol, Arnica Montana Extract, Cannabis Sativa Seed Oil, Cyclohexasiloxane, Cyclopentasiloxane, Glycerin, PEG/PPG-18/18 Dimethicone, Menthane Carboxamidoethyl Acetate, Phenoxyethanol, Potassium Hydroxide, Sodium Chloride, Water (purified)

Questions?(800)645-2158

Principal Panel-Tube

Dr Sayman Wonder Rub  

Maximum Strength

4% Lidocaine

Pain Relieving 

NET WT. 4.0 oz (113g)

Principal Panel - Carton

Dr.Sayman's Wonder Rub 

Maximum Strength

4% Lidocaine

Pain Relieving 

NET WT. 4.0 oz (113g)

INGREDIENTS AND APPEARANCE

DR SAYMANS WONDER RUB 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-384
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
N-((ETHOXYCARBONYL)METHYL)-P-MENTHANE-3-CARBOXAMIDE (UNII: Q6CA504696)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-384-22	1 in 1 CARTON	02/21/2019
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/21/2019

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(11527-384)