recelltis

recelltis
SPL v1
SPL
SPL Set ID 67f1c6b1-28a2-2b14-e053-2991aa0a656c
Route
topical
Published
Effective Date 2018-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (400 [USP'U]) neomycin (3.5 mg) polymyxin b (5000 [USP'U]) lidocaine (20 mg)
Inactive Ingredients
coenzyme q10, (2z)- polysorbate 80 petrolatum cetostearyl alcohol carboxymethylcellulose water phenoxyethanol peg-6 sorbitan oleate alpha-tocopherol acetate zinc gluconate cetyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2018-03-21
Purpose

First aid antibiotic First aid antibiotic First aid antibiotic Local anesthetic

Description

Drug Facts

Medication Information

Warnings

For external use only

Uses

First aid to prevent infection, for temporary relief of pain or discomfort, and helps promote skin repair in minor:

  • Cuts
  • Scrapes
  • Burns
Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Local anesthetic

Directions

Adults and children 2 years of age or older:

  • clean the affected area
  • apply a small amount (thin layer) on the area 1 to 3 times daily
  • may be covered with sterile bandage

Children under 2 years of age: ask a doctor

Other Information
  • store at 15° to 30°C (59° to 86°F)
  • protect from freezing and avoid excessive heat
Inactive Ingredients

Carboxymethyl Cellulose, Cetostearyl Alcohol, Cetyl Alcohol, CoEnzyme Q-10, Purified Water, Phenoxyethanol, Polysorbate 80, Sorbitan Oleate, Tocopheryl Acetate , White Petrolatum, Zinc Gluconate.

Description

Drug Facts

Principal Display Panel

Section 50565-1

Keep out of reach of children.

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

Do Not Use
  • in the eyes
  • if you are allergic to any of the ingredients
  • over large areas of the body
Stop Use and Ask A Doctor If

  • you need to use longer than 1 week
  • rash or other allergic reaction develops
  • condition persists or gets worse
Active Ingredients (in Each Gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5mg (equivalent to 3.5 mg of neomycin base)

Polymyxin B Sulfate 5,000 units

Lidocaine Hydrochloride 20 mg

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Recelltis +pain & Itch Relief First Aid Cream

Drug Facts

Structured Label Content

Warnings

For external use only

Uses

First aid to prevent infection, for temporary relief of pain or discomfort, and helps promote skin repair in minor:

  • Cuts
  • Scrapes
  • Burns
Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Local anesthetic

Directions

Adults and children 2 years of age or older:

  • clean the affected area
  • apply a small amount (thin layer) on the area 1 to 3 times daily
  • may be covered with sterile bandage

Children under 2 years of age: ask a doctor

Other Information
  • store at 15° to 30°C (59° to 86°F)
  • protect from freezing and avoid excessive heat
Inactive Ingredients (Inactive ingredients)

Carboxymethyl Cellulose, Cetostearyl Alcohol, Cetyl Alcohol, CoEnzyme Q-10, Purified Water, Phenoxyethanol, Polysorbate 80, Sorbitan Oleate, Tocopheryl Acetate , White Petrolatum, Zinc Gluconate.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Do Not Use (Do not use)
  • in the eyes
  • if you are allergic to any of the ingredients
  • over large areas of the body
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

  • you need to use longer than 1 week
  • rash or other allergic reaction develops
  • condition persists or gets worse
Active Ingredients (in Each Gram) (Active Ingredients (in each gram))

Bacitracin Zinc 400 units

Neomycin Sulfate 5mg (equivalent to 3.5 mg of neomycin base)

Polymyxin B Sulfate 5,000 units

Lidocaine Hydrochloride 20 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Recelltis +pain & Itch Relief First Aid Cream (ReCellTis +Pain & Itch Relief First Aid Cream)

Drug Facts

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:32.333829 · Updated: 2026-03-14T22:55:04.352870