1473 D-cerin, Ndc 67777-147-30

1473 D-cerin, Ndc 67777-147-30
SPL v4
SPL
SPL Set ID 7ea47a7e-12af-9290-e053-2a91aa0a065f
Route
TOPICAL
Published
Effective Date 2019-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (33 g)
Inactive Ingredients
Propylparaben Sodium Chloride Water Paraffin Peg-30 Dipolyhydroxystearate Lanolin Alcohols Dmdm Hydantoin Mineral Oil Methylparaben Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-20

Description

Petrolatum 33%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Petrolatum 33%

Label

Use(s)

• Temporarily protects and helps relieve dry, chapped, or cracked skin

• Helps protect skin from the drying effects of wind and cold weather

Warnings

For External Use Only

Directions

Apply as needed or as directed by a physician.

Do Not Use

• On deep puncture wounds • Animal bites • Serious burns.

Questions?

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Active Ingredient

Petrolatum 33%

Other Information

• Store at room temperature 15º-30ºC (59° - 86°F)

• Tamper evident. Do not use if seal is damaged.

Inactive Ingredients

DMDM Hydantoin, Lanolin Alcohol, Methyl Paraben, Mineral Oil, Paraffin, PEG 30 Dipolyhydroxystearate, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride

Avoid Contact With Eyes.

In case of contact, flush thoroughly with water.

Stop Use and Ask A Doctor If
  • Conditions worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children

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


Structured Label Content

Label

Use(s)

• Temporarily protects and helps relieve dry, chapped, or cracked skin

• Helps protect skin from the drying effects of wind and cold weather

Purpose

Skin Protectant

Warnings

For External Use Only

Directions

Apply as needed or as directed by a physician.

Do Not Use (Do not use)

• On deep puncture wounds • Animal bites • Serious burns.

Questions?

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Active Ingredient (Active ingredient)

Petrolatum 33%

Other Information (Other information)

• Store at room temperature 15º-30ºC (59° - 86°F)

• Tamper evident. Do not use if seal is damaged.

Inactive Ingredients

DMDM Hydantoin, Lanolin Alcohol, Methyl Paraben, Mineral Oil, Paraffin, PEG 30 Dipolyhydroxystearate, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride

Avoid Contact With Eyes. (Avoid contact with eyes.)

In case of contact, flush thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Conditions worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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