SPL v1
SPL
SPL Set ID ac4c2623-6a84-4908-b018-956bb978aa56
Route
TOPICAL
Published
Effective Date 2019-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (20 mg) Zinc Cation (1 mg)
Inactive Ingredients
Cetyl Alcohol Diazolidinyl Urea Methylparaben Glyceryl Stearate Se Propylene Glycol Propylene Glycol Monostearate Propylparaben Water Citric Acid Monohydrate Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-02-09
Description

Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%

Purpose

Topical analgesic Skin protectant

Medication Information

Purpose

Topical analgesic

Skin protectant

Description

Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%

Uses

For temporary relief from pain and itching associated with :

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • rashes due to poison ivy, poison oak, and poison sumac

Dries the oozing and weeping of poison

  • ivy
  • oak
  • sumac
Warnings

For external use only

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine , even one taken by the mouth.

Ask a Doctor before use

  • on chicken pox
  • on measles

When using this product avoid contact with eyes.

Stop use and ask a doctor if

  • conditions worsen or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur agian within a few days

Directions
  • do not use more than directed
  • adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily
  • children under 2 years of age , consult a doctor

Other Information

  • Store at controlled room temperature 20°-25°C (68° - 77°F)
  • Close the cap tightly after use
Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc Acetate 0.1%

Inactive Ingredients

Cetyl Alcohol, Citric Acid, Diazolldinyl Urea, Glyceryl Sterate, Methylparaben, Polyethylene Glycol Monosterate  1000, Propylene Glycol, Propylparaben, Sodium Citrate , Purified Water

Principal Display Panel Can 

Welly Calm Balm First aid NDC 72663-069-59



Extra Strength ANTI -ITCH cream



2% Diphenhydramine HCL topical analgesic

0.1% Zinc Acetate skin protectant

NET WT 0.57 oz (16g) 

2- Tubes  1.14 oz ( 32g)

Principal Display Panel .57 Oz  Tube

 Welly First aid    NDC 72663-069-59

Extra Strength ANTI -ITCH cream

2% Diphenhydramine HCL topical analgesic

0.1% Zinc Acetate skin protectant

NET WT 0.57 oz (16g)

Keep This and All Drugs Out of the Reach of Children.

If swallowed get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses

For temporary relief from pain and itching associated with :

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • rashes due to poison ivy, poison oak, and poison sumac

Dries the oozing and weeping of poison

  • ivy
  • oak
  • sumac
Purpose

Topical analgesic

Skin protectant

Warnings

For external use only

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine , even one taken by the mouth.

Ask a Doctor before use

  • on chicken pox
  • on measles

When using this product avoid contact with eyes.

Stop use and ask a doctor if

  • conditions worsen or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur agian within a few days

Directions
  • do not use more than directed
  • adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily
  • children under 2 years of age , consult a doctor

Other Information

  • Store at controlled room temperature 20°-25°C (68° - 77°F)
  • Close the cap tightly after use
Active Ingredients (Active ingredients)

Diphenhydramine hydrochloride 2%

Zinc Acetate 0.1%

Inactive Ingredients (Inactive ingredients)

Cetyl Alcohol, Citric Acid, Diazolldinyl Urea, Glyceryl Sterate, Methylparaben, Polyethylene Glycol Monosterate  1000, Propylene Glycol, Propylparaben, Sodium Citrate , Purified Water

Principal Display Panel Can  (Principal Display Panel -Can )

Welly Calm Balm First aid NDC 72663-069-59



Extra Strength ANTI -ITCH cream



2% Diphenhydramine HCL topical analgesic

0.1% Zinc Acetate skin protectant

NET WT 0.57 oz (16g) 

2- Tubes  1.14 oz ( 32g)

Principal Display Panel .57 Oz  Tube (Principal Display Panel .57 oz  Tube)

 Welly First aid    NDC 72663-069-59

Extra Strength ANTI -ITCH cream

2% Diphenhydramine HCL topical analgesic

0.1% Zinc Acetate skin protectant

NET WT 0.57 oz (16g)

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)

If swallowed get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:45.536332 · Updated: 2026-03-14T22:55:25.290849