moisturizing skin relief lotion, ndc-0363-5995

moisturizing skin relief lotion, ndc-0363-5995
SPL v3
SPL
SPL Set ID fc678e80-e63d-e3fe-e053-6394a90aa7d6
Route
topical
Published
Effective Date 2023-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (1200 mg)
Inactive Ingredients
phenoxyethanol shea butter sodium chloride oat kernel oil oatmeal petrolatum water cetyl alcohol ethylhexylglycerin glycerin isopropyl palmitate oat distearyldimonium chloride sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-09-11
Purpose

Skin protectant

Description

Dimethicone 1.2%

Medication Information

Warnings

For External use only

Uses
  • Helps prevent and temporarily protects chafed, chapped or cracked skin.
  • Helps protect from the drying effects of wind and cold weather.
Purpose

Skin protectant

Directions

Apply as necessary

Inactive Ingredients

Water (Aqua), Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Butyrospermum Parkii (Shea) Butter, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Sodium Chloride.

Description

Dimethicone 1.2%

Section 51945-4

Do Not Use On
  • Deep or puncture wounds
  • animal bites.
  • Serious burns.
Active Ingredient

Dimethicone 1.2%

Questions Or Comments?

1-800-925-4733

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.

Structured Label Content

Warnings

For External use only

Uses
  • Helps prevent and temporarily protects chafed, chapped or cracked skin.
  • Helps protect from the drying effects of wind and cold weather.
Purpose

Skin protectant

Directions

Apply as necessary

Inactive Ingredients

Water (Aqua), Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Butyrospermum Parkii (Shea) Butter, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Sodium Chloride.

Section 51945-4 (51945-4)

Do Not Use On (Do not use on)
  • Deep or puncture wounds
  • animal bites.
  • Serious burns.
Active Ingredient

Dimethicone 1.2%

Questions Or Comments? (Questions or Comments?)

1-800-925-4733

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 contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:17.181050 · Updated: 2026-03-14T23:03:15.788850