HELOCAINE COLD SORE FEVER BLISTER TREATMENT- tetracaine, mineral ointment

Helocaine Cold Sore Fever Blister Treatment by

Drug Labeling and Warnings

Helocaine Cold Sore Fever Blister Treatment by is a Otc medication manufactured, distributed, or labeled by Pagari Life Science Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Tetracaine 2%

Mineral oil 74.4%

Purpose

Topical analgesic

Skin protectant

Uses

• for the temporary relief of pain and itching associated with fever blisters and cold sores
• helps prevent and temporarily protects chapped or cracked lips
• helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only.

Do not use

• on deep or puncture wounds animal bites serious burns
• in large quantities, particularly over raw surfaces or blistered areas

When using this product

• do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• allergic reaction (blister or rash worsens) to any of the ingredients

Keep out of reach of children.

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

Directions

Adults and children 2 years of age and older

• apply to affected area not more than 3 to 4 times daily

Children under the age of 2

• consult a doctor

Other information

• store at 20º - 25º C (68º - 77º F)

Inactive ingredients

peppermint oil, polyethylene, polyethylene oxide, polyethylene glycol, sodium carboxymethylcellulose

Questions or comments?

call 1- (877) 513-3057 (toll-free)

Package labeling

INGREDIENTS AND APPEARANCE

HELOCAINE COLD SORE FEVER BLISTER TREATMENT 
tetracaine, mineral ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83609-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	20 mg  in 1 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	744 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83609-212-02	1 in 1 BOX	05/01/2024
1		3 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	05/01/2024

Labeler - Pagari Life Science Corp. (119031253)