1165 First Aid Burn Cream Ndc 67777-007-50

1165 First Aid Burn Cream Ndc 67777-007-50
SPL v3
SPL
SPL Set ID 826e08be-dffa-5a27-e053-2a91aa0a8701
Route
TOPICAL
Published
Effective Date 2024-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (50 mg)
Inactive Ingredients
Butylated Hydroxytoluene Edetic Acid Methylparaben Sodium Propylparaben Sodium Ceteth-20 Methylcellulose (4000 Cps) Isopropyl Myristate Water Cetostearyl Alcohol Glycerin Glyceryl Monostearate Dimethicone 350

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-17
Description

Lidocaine HCl 0.5%

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Lidocaine HCl 0.5%

Uses

For the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritation, cuts, scrapes

Section 50565-1

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

Warnings

For external use only

1165 Label

Directions

Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 to 4 times daily
  • may be covered with a sterile bandage

Children under 2 years:

  • consult a doctor
Do Not Use
  • in the eyes
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns
  • in large quantities, particularly over raw surfaces or blistered areas
1165ub 10 Label

1165UB-10

1165ub 25 Label

Active Ingredient

Lidocaine HCl 0.5%

Other Information
  • store in a cool, dry area 15°-25° C (59°-79° F)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

Butylated Hydroxytoluene, Cetomacrogol, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

Stop Use and Ask A Doctor If
  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days
If Pregnant Or Breast Feeding,

ask a health care professional before use.

Structured Label Content

Uses

For the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritation, cuts, scrapes

Section 50565-1 (50565-1)

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

Purpose

Topical analgesic

Warnings

For external use only

1165 Label

Directions

Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 to 4 times daily
  • may be covered with a sterile bandage

Children under 2 years:

  • consult a doctor
Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns
  • in large quantities, particularly over raw surfaces or blistered areas
1165ub 10 Label (1165UB-10 Label)

1165UB-10

1165ub 25 Label (1165UB-25 Label)

Active Ingredient

Lidocaine HCl 0.5%

Other Information
  • store in a cool, dry area 15°-25° C (59°-79° F)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

Butylated Hydroxytoluene, Cetomacrogol, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days
If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health care professional before use.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.586233 · Updated: 2026-03-14T23:02:26.872598