baby balm stick 0.65oz

baby balm stick 0.65oz
SPL v1
SPL
SPL Set ID 20cf3bb8-4ab8-2980-e063-6294a90ad631
Route
topical
Published
Effective Date 2024-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (30 g)
Inactive Ingredients
yellow wax sheanut oil tocopherol panthenol glycerin ceresin levomenol mineral oil butylated hydroxytoluene polyisobutylene (1300 mw) microcrystalline wax

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-08-29

Purpose

Skin Protectant (Ointment)

Description

Petrolatun 30%


Medication Information

Warnings

For external use only

Purpose

Skin Protectant (Ointment)

Directions

Apply as needed.

Other Information

For best product quality, store below 113°F/45°C.

Inactive Ingredients

Mineral Oil

polyisobutene

polyisobutene

beeswax

microcrystalline wax

butyrospermum parkii (shea butter) oil

BHT

Bisabolol

Glycerin

Tocopherol

Panthenol

Description

Petrolatun 30%

Use
  • temporarily protects minor;
  • cut
  • scrapes
  • burns
  • temporarily protects and helps relieve chapped or cracked skin and lips
  • helps protect from the drying effects of wind and cold weather
Label

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

Petrolatun 30%

When Using This Product

When using this product do not get into eyes.

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7days 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

Purpose

Skin Protectant (Ointment)

Directions

Apply as needed.

Other Information (Other information)

For best product quality, store below 113°F/45°C.

Inactive Ingredients (Inactive ingredients)

Mineral Oil

polyisobutene

polyisobutene

beeswax

microcrystalline wax

butyrospermum parkii (shea butter) oil

BHT

Bisabolol

Glycerin

Tocopherol

Panthenol

Use
  • temporarily protects minor;
  • cut
  • scrapes
  • burns
  • temporarily protects and helps relieve chapped or cracked skin and lips
  • helps protect from the drying effects of wind and cold weather
Label (label)

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

Petrolatun 30%

When Using This Product (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 7days 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

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