Blister Balm
FDA Label NDC 70996-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Floratech Botanicals, Llc for the product Blister Balm (NDC 70996-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, indications & usage, warnings:, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Glycerin (25%)

Purpose

Lip Protectant

Indications & Usage

  • Temporarily protects and helps relieve chapped or cracked lips
  • For the temporary relief of pain and itching associated with minor lip irritation
  • Helps protect lips from the drying effects of wind and cold weather

Warnings:

For External Use Only: Do not use this product in or near the eyes. Rinse with water to remove. Do not use on broken skin or open wounds.

Stop Use and ask a Physician if a rash occurs, and worsens or if symptoms persist for more than 7 days.

When using this product you may feel a tingling or stinging sensation which should go away in a short time.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and in case of allergic reaction, get medical help or contact a Poison Control Center immediately. (1800-222-1222)

Directions

Apply daily as a prophylactic to maintain optimum lip fitness. Use especially during exposure of the lips to heat, sun or cold weather or conditions known to contribute to chapped, cracked or dry lips or cold sore/fever blister outbreaks. Reapply as often as necessary to maintain soft, supple lips, or every 2-4 hours. For best results, apply as a base coat on the lips under a waterproof sunscreen during sun exposure. Do not share this product with anyone. Do not use this product if you are allergic to any ingredient in this product.

Other Information

Store at room temperature 68 to 77°F (20 to 25°C). For best results avoid brushing teeth or drinking soft drinks or juice for up to one hour after application of this product.

Inactive Ingredients

Benzyl Alcohol, Clove (syzygium aromaticum) bud oil, Commint oil (menthe arvensis) Crystals, Hydrolyzed Jojoba Esters, Jojobo Esters, Lemon (melissa officinalis) balm oil, Peppermint (menthe piperita) oil, Propylene Glycol, Stevia and Xylitol (natural sweeteners)

Questions Or Comments?

1-866-3COLDSOR (1-866-326-5376)

M-F 9am-5pm or visit our website at www.killmycoldsore.com

Distributed by: JojobaDerm Labs, 291 E El Prado Ct., Chandler, AZ 85225

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