dolgencorp, llc antibiotic cream drug facts

dolgencorp, llc antibiotic cream drug facts
SPL v6
SPL
SPL Set ID efaf3ea5-0a2f-414f-96eb-7e8cfba9e901
Route
topical
Published
Effective Date 2021-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
neomycin (3.5 mg) pramoxine (10 mg) polymyxin b (10000 [USP'U])
Inactive Ingredients
methylparaben mineral oil poloxamer 188 propylene glycol water petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2011-01-14
Purpose

First aid antibiotic External analgesic

Description

Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 10,000 units as polymyxin B sulfate Pramoxine HCl 10 mg

Medication Information

Warnings

For external use only.

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

  • •
    cuts
  • •
    scrapes
  • •
    burns
Purpose

First aid antibiotic

External analgesic

Directions
  • •
    adults and children 2 years of age or older:
  • •
    clean the affected area
  • •
    apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • •
    may be covered with a sterile bandage
  • •
    children under 2 years of age: ask a doctor
Other Information
  • •
    store at 20°-25°C (68°-77°F)
Inactive Ingredients

emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

Description

Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 10,000 units as polymyxin B sulfate Pramoxine HCl 10 mg

Principal Display Panel

Compare to the active ingredients of Neosporin® + Pain Relief

First Aid Antibiotic/Pain Relieving Cream

Antibiotic Cream

Neomycin Sulfate – Polymyxin B Sulfate

Pramoxine HCl

+ PAIN RELIEF

First Aid to Help Prevent Infection in Minor Cuts, Scrapes & Burns

Maximum Strength Pain Relief

NET WT 1 OZ (28 g)

Do Not Use
  • •
    if you are allergic to any of the ingredients
  • •
    in the eyes
  • •
    over large areas of the body
Questions Or Comments?

1-888-309-9030

Stop Use and Ask A Doctor If
  • •
    you need to use longer than 1 week
  • •
    condition persists or gets worse
  • •
    symptoms persist for more than 1 week, or clear up and occur again within a few days
  • •
    rash or other allergic reaction develops
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Active Ingredients (in Each Gram)

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

Ask A Doctor Before Use If You Have
  • •
    deep or puncture wounds
  • •
    animal bites
  • •
    serious burns

Structured Label Content

Warnings

For external use only.

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

  • •
    cuts
  • •
    scrapes
  • •
    burns
Purpose

First aid antibiotic

External analgesic

Directions
  • •
    adults and children 2 years of age or older:
  • •
    clean the affected area
  • •
    apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • •
    may be covered with a sterile bandage
  • •
    children under 2 years of age: ask a doctor
Other Information (Other information)
  • •
    store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

Principal Display Panel

Compare to the active ingredients of Neosporin® + Pain Relief

First Aid Antibiotic/Pain Relieving Cream

Antibiotic Cream

Neomycin Sulfate – Polymyxin B Sulfate

Pramoxine HCl

+ PAIN RELIEF

First Aid to Help Prevent Infection in Minor Cuts, Scrapes & Burns

Maximum Strength Pain Relief

NET WT 1 OZ (28 g)

Do Not Use (Do not use)
  • •
    if you are allergic to any of the ingredients
  • •
    in the eyes
  • •
    over large areas of the body
Questions Or Comments? (Questions or comments?)

1-888-309-9030

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • •
    you need to use longer than 1 week
  • •
    condition persists or gets worse
  • •
    symptoms persist for more than 1 week, or clear up and occur again within a few days
  • •
    rash or other allergic reaction develops
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:38.269382 · Updated: 2026-03-14T23:03:48.236290