Family Wellness Anti-itch Cream, 28g

Family Wellness Anti-itch Cream, 28g
SPL v4
SPL
SPL Set ID fde2069b-344e-46da-bb95-c5113e0f35d6
Route
TOPICAL
Published
Effective Date 2019-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (2 g) Zinc Cation (0.1 g)
Inactive Ingredients
Cetyl Alcohol Glyceryl Stearate Se Laureth-23 Methylparaben Mineral Oil Petrolatum Propylene Glycol Propylparaben Stearic Acid Stearyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-29

Description

Active Ingredients Diphenhydramine hydrochloride 2% Zinc acetate 0.1%


Medication Information

Warnings and Precautions

Warnings

. For external use only

Do not use

•avoid contact with eyes When using this product

Ask a doctor before use

•on chicken pox  •on measles

Stop use and ask a doctor if

  • over large areas of the body
  • with any other product containing diphenhydramine including those taken orally
  • symptoms last for more than 7 days
  • the condition gets worse
  • symptoms clear up and then occur again within a few days
Indications and Usage

for temprary relief from pain and itching associated Uses

with insect bites , sunburn and mior skin irritations. Dries the

oozing and weeping of poison: •ivy  •oak  •sumac

Dosage and Administration

Directions

•for adults and children over 2 years of age: apply to affected

area not more than 3 to 4 times daily

•children under 2 years of age: ask a doctor before use

Description

Active Ingredients Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

Label

Section 50565-1

. If swallowed, get medical help Keep out of reach of children

or contact a Poison Control Center right away.

Section 51727-6

cetyl alcohol, glyceryl stearate se, Inactive ingredients

laureth-23, methylparaben, mineral oil, petrolatum, propylene

glycol, propylparaben, stearic acid, stearic alcohol, water

Section 53413-1

1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

Section 55105-1

Purpose

Topical analgesic

Skin protectant

Section 55106-9

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Section 60561-8

store at room temperature 59° - 86° F Other information

(15° - 30° C).


Structured Label Content

Label (label)

Indications and Usage (34067-9)

for temprary relief from pain and itching associated Uses

with insect bites , sunburn and mior skin irritations. Dries the

oozing and weeping of poison: •ivy  •oak  •sumac

Dosage and Administration (34068-7)

Directions

•for adults and children over 2 years of age: apply to affected

area not more than 3 to 4 times daily

•children under 2 years of age: ask a doctor before use

Warnings and Precautions (34071-1)

Warnings

. For external use only

Do not use

•avoid contact with eyes When using this product

Ask a doctor before use

•on chicken pox  •on measles

Stop use and ask a doctor if

  • over large areas of the body
  • with any other product containing diphenhydramine including those taken orally
  • symptoms last for more than 7 days
  • the condition gets worse
  • symptoms clear up and then occur again within a few days
Section 50565-1 (50565-1)

. If swallowed, get medical help Keep out of reach of children

or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

cetyl alcohol, glyceryl stearate se, Inactive ingredients

laureth-23, methylparaben, mineral oil, petrolatum, propylene

glycol, propylparaben, stearic acid, stearic alcohol, water

Section 53413-1 (53413-1)

1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Skin protectant

Section 55106-9 (55106-9)

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Section 60561-8 (60561-8)

store at room temperature 59° - 86° F Other information

(15° - 30° C).


Advanced Ingredient Data


Raw Label Data

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