Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID fefbe351-1cd9-4a2f-a43d-51e2c4eb180b
Route
TOPICAL
Published
Effective Date 2013-09-04
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 Monostearate Laureth-23 Methylparaben Mineral Oil Petrolatum Propylene Glycol Propylparaben Stearic Acid Stearyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-11-01

Description

Inactive Ingredients - cetyl alcohol, glycerol stearate, laureth-23, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, stearic acid, stearyl alcohol, water


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses  for temporary relief from pain and itching associated

with insect bites, sunburn and minor 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 or 4 times per day

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

Description

Inactive Ingredients - cetyl alcohol, glycerol stearate, laureth-23, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, stearic acid, stearyl alcohol, water

Section 44425-7

Other information - store at room temperature 59 - 86 F (15 - 30 C)

Section 50565-1

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

or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if:

-symptoms last for more than 7 days

-the condition gets worse

-symptoms clear up and then occur again within a few days

Section 50567-7

When using this product - avoid contact with eyes

Section 50569-3

Ask a doctor before use

-on chicken pox

-on measles

Section 50570-1

Do not use

-over large areas of the body

-with any other product containing diphenhydramine,

including those taken orally

Section 51727-6

Inactive Ingredients - cetyl alcohol, glycerol stearate,

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

glycol, propylparaben, stearic acid, stearyl alcohol, water

Section 51945-4

Section 53413-1

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

Section 55105-1

Purpose

---Topical analgesic

---Skin protectant

Section 55106-9

Active Ingredients

Diphenhydramine hydrochloride 2 %

Zinc acetate 0.1 %


Structured Label Content

Indications and Usage (34067-9)

Uses  for temporary relief from pain and itching associated

with insect bites, sunburn and minor 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 or 4 times per day

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information - store at room temperature 59 - 86 F (15 - 30 C)

Section 50565-1 (50565-1)

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

or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

-symptoms last for more than 7 days

-the condition gets worse

-symptoms clear up and then occur again within a few days

Section 50567-7 (50567-7)

When using this product - avoid contact with eyes

Section 50569-3 (50569-3)

Ask a doctor before use

-on chicken pox

-on measles

Section 50570-1 (50570-1)

Do not use

-over large areas of the body

-with any other product containing diphenhydramine,

including those taken orally

Section 51727-6 (51727-6)

Inactive Ingredients - cetyl alcohol, glycerol stearate,

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

glycol, propylparaben, stearic acid, stearyl alcohol, water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Purpose

---Topical analgesic

---Skin protectant

Section 55106-9 (55106-9)

Active Ingredients

Diphenhydramine hydrochloride 2 %

Zinc acetate 0.1 %


Advanced Ingredient Data


Raw Label Data

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