drug facts

drug facts
SPL v3
SPL
SPL Set ID b7b2f64e-27b4-4c71-95cf-78b37540f975
Route
topical
Published
Effective Date 2018-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (20 mg)
Inactive Ingredients
petrolatum ceresin ethylhexyl palmitate squalane myristyl myristate castor oil myristyl lactate cetyl alcohol myristyl laurate myristyl alcohol butylated hydroxytoluene menthol, unspecified form .alpha.-tocopherol octyldodecanol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-10-15
Purpose

Dimethicone - Skin protectant

Description

Dimethicone 2%

Medication Information

Warnings

For external use only

Uses
  • helps prevent and temporarily protects chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Purpose

Dimethicone - Skin protectant

Directions

apply as needed

Inactive Ingredients

ozokerite, petrolatum, ethylhexyl palmitate, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetatate [vitamin E]

Description

Dimethicone 2%

Questions?

1-877-636-2677 MON-FRI 9AM to 5PM (EST) softlips.com

Active Ingredients

Dimethicone 2%

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 contact a Poison Control Center right away.

Package/label Principal Display Panel

Structured Label Content

Warnings

For external use only

Uses
  • helps prevent and temporarily protects chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Purpose

Dimethicone - Skin protectant

Directions

apply as needed

Inactive Ingredients (Inactive ingredients)

ozokerite, petrolatum, ethylhexyl palmitate, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetatate [vitamin E]

Questions?

1-877-636-2677 MON-FRI 9AM to 5PM (EST) softlips.com

Active Ingredients (Active ingredients)

Dimethicone 2%

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

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:52.686299 · Updated: 2026-03-14T23:05:57.575147