Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 9838019c-79ea-440d-9ee0-7286294f2b24
Route
TOPICAL
Published
Effective Date 2010-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (.03 mg)
Inactive Ingredients
Water Petrolatum Glycerin Steareth-2 Cetyl Alcohol Benzyl Alcohol Laureth-23 Magnesium Aluminum Silicate Carbomer 934 Potassium Sorbate Sodium Hydroxide Aloe Vera Leaf

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 1998-04-15

Description

Dimethicone 3%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Dimethicone 3%

Uses
  • Temporarily protects and helps relieve chapped or cracked skin and lips.
  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings

For external use only.

Directions
For skin protection:



  • Apply as needed.
For diaper rash:



  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
  • Apply liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns

Active Ingredient

Dimethicone 3%

Other Information


Store at 15oC - 30oC (59oF - 86oF).

Inactive Ingredients


Water, Petrolatum, Glycerin, Steareth-2, Cetyl Alcohol, Benzyl Alcohol, Laureth-23, Magnesium Aluminum Silicate, Carbomer, Potassium Sorbate, Sodium Hydroxide, Aloe Barbadensis Leaf Juice.







Principal Display Panel

NDC 43553-3248-4



ConvaTec

ALOE VESTATM

Skin Conditioner 2



MOISTURIZE



SKIN PROTECTANT



Dermatologist Recommended



Fragrance Free

Softens

Moisturizes



NET WT. 4 fl.oz.(118mL)

Case Order No. 324804

When Using This Product

do not get into eyes.

Stop Use and Ask A Doctor If
  • condition 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 consult a Poison Control Center right away.


Structured Label Content

Uses
  • Temporarily protects and helps relieve chapped or cracked skin and lips.
  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Purpose

Skin Protectant

Warnings

For external use only.

Directions
For skin protection:



  • Apply as needed.
For diaper rash:



  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
  • Apply liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns

Active Ingredient

Dimethicone 3%

Other Information


Store at 15oC - 30oC (59oF - 86oF).

Inactive Ingredients


Water, Petrolatum, Glycerin, Steareth-2, Cetyl Alcohol, Benzyl Alcohol, Laureth-23, Magnesium Aluminum Silicate, Carbomer, Potassium Sorbate, Sodium Hydroxide, Aloe Barbadensis Leaf Juice.







Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 43553-3248-4



ConvaTec

ALOE VESTATM

Skin Conditioner 2



MOISTURIZE



SKIN PROTECTANT



Dermatologist Recommended



Fragrance Free

Softens

Moisturizes



NET WT. 4 fl.oz.(118mL)

Case Order No. 324804

When Using This Product (When using this product)

do not get into eyes.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition 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 consult a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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