6ba2761c-4c05-498b-a012-e95843c20573

SPL v3
SPL
SPL Set ID 6ba2761c-4c05-498b-a012-e95843c20573
Route
topical
Published
Effective Date 2022-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (400 mg)
Inactive Ingredients
petrolatum glycerin cod liver oil sorbitan sesquioleate lanolin yellow wax talc .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-05-31

Purpose

Skin protectant 

Description

Zinc Oxide 40%


Medication Information

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Purpose

Skin protectant 

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Inactive Ingredients

Petrolatum, Glycerin, Cod Liver Oil, Sorbitan Sesquioleate, Lanolin, Beeswax, Talc, Tocopheryl Acetate, Fragrance

Description

Zinc Oxide 40%

Purpose 

Skin protectant 

Warnings 

For external use only

Drug Fact 

Active Ingredient 

Zinc Oxide 40%

Other Information 

store between 20 and 25 C (68 and 77 F)

When Using This Product 
  • avoid contact with eyes
Stop Use and Ask A Doctor If
  • if condition worsens or does not improve in 7 days. This may be a sign of a serious condition.
Principal Display Panel Tube

Target Up and Up NDC 11673-728-40

Maximum Strength diaper rash Paste

Zino Oxide 40%

Skin Protectant

NET WT 4.0 OZ (113.3g)

Keep Out of the Reach of Children

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

Principal Display Panel  Carton 

Target Up and Up       NDC 11673-728-40

Maximum Strength diaper rash Paste

Zino Oxide 40%

Skin Protectant

NET WT 4.0 OZ (113.3g)


Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Inactive Ingredients (Inactive ingredients)

Petrolatum, Glycerin, Cod Liver Oil, Sorbitan Sesquioleate, Lanolin, Beeswax, Talc, Tocopheryl Acetate, Fragrance

Purpose 

Skin protectant 

Warnings 

For external use only

Drug Fact 

Active Ingredient  (Active ingredient )

Zinc Oxide 40%

Other Information  (Other information )

store between 20 and 25 C (68 and 77 F)

When Using This Product  (When using this product )
  • avoid contact with eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • if condition worsens or does not improve in 7 days. This may be a sign of a serious condition.
Principal Display Panel Tube (Principal Display Panel -Tube)

Target Up and Up NDC 11673-728-40

Maximum Strength diaper rash Paste

Zino Oxide 40%

Skin Protectant

NET WT 4.0 OZ (113.3g)

Keep Out of the Reach of Children (Keep out of the reach of children)

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

Principal Display Panel  Carton 

Target Up and Up       NDC 11673-728-40

Maximum Strength diaper rash Paste

Zino Oxide 40%

Skin Protectant

NET WT 4.0 OZ (113.3g)


Advanced Ingredient Data


Raw Label Data

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