PURE PRIMAL DELAY- lidocaine hcl cream

PURE PRIMAL DELAY by

Drug Labeling and Warnings

PURE PRIMAL DELAY by is a Otc medication manufactured, distributed, or labeled by Prodigy Media Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCL 4%

Purpose

External Analgesic

Uses

For the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations

Warnings

• For external use only.
• Avoid contact with eyes

Stop use and ask a doctor if

• Condition worsens or symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days
• Do not use in large quantities, particularly over raw surfaces or blistered areas. Do not exceed the recommended daily dosage unless directed by a doctor.

Do not use

• On wounds or damaged skin.

Keep out of reach of children

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

Direction

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: do not use, consult a physician.

Other information

Do not use if seal is broken.

Inactive ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract,C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil,
Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid,Tea Tree Oil, Triethanolamine.

SPL UNCLASSIFIED SECTION

Questions? 866-488-0066

Product label

PURE PRIMAL DELAY LABEL

PURE PRIMAL DELAY BOX

INGREDIENTS AND APPEARANCE

PURE PRIMAL DELAY 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70171-0060
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ELOSULFASE ALFA (UNII: ODJ69JZG85)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70171-0060-1	1 in 1 CARTON	07/27/2025
1		28 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 Drug	M017	07/27/2025

Labeler - Prodigy Media Inc (080011622)