OTC Medication Information: Lana1263

LANA1263- lanolin ointment
Blossom Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

Active ingredient Purpose
Lanolin USP 50% Skin Protectant

Purpose:

  • Helps prevent and treat diaper dermatitis
  • Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness

Warnings

For External Use Only

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

Indications & Usage

  • Avoid contact with eyes
  • Do not apply to deep or puncture wounds
  • If condition worsens, or does not improve within 7 days, consult a doctor

Dosage & Administration

  • Gently cleanse and dry area
  • Apply liberally to affected area as needed

Other information:

  • Store at room temperature 20 deg C to 25 deg C 68 deg F to 77 deg F

Inactive Ingredients

Beeswax (White), EDTA, Emulsifying wax, Lanolin alcohol, Lavender perfume, Mineral oil, Petrolatum, Purified water, Sodium borate

Principal Display Panel

Lana1263 Ointment

Lana1263.jpg

Lana1263
(click image for full-size original)
LANA1263
lanolin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61767-232
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANOLIN (LANOLIN) LANOLIN 50 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WHITE WAX
LANOLIN ALCOHOLS
MINERAL OIL
SODIUM BORATE
WATER
EDETIC ACID
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61767-232-01 5 g in 1 PACKET None
2 NDC:61767-232-02 15 g in 1 PACKET None
3 NDC:61767-232-03 71 g in 1 JAR None
4 NDC:61767-232-04 113 g in 1 TUBE None
5 NDC:61767-232-05 127.5 g in 1 JAR None
6 NDC:61767-232-06 396.8 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 10/23/2014
Labeler — Blossom Pharmaceuticals (677381470)

Revised: 10/2014 Blossom Pharmaceuticals

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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