AQUANIL HC- hydrocortisone lotion

Aquanil HC by

Drug Labeling and Warnings

Aquanil HC by is a Otc medication manufactured, distributed, or labeled by Person and Covey. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone

Stop Use and Ask a Doctor

Stop use and ask a doctor if:

-Condition worsens

-If symptoms persit for more than 7 days or clear up and occur again within a few days. Discocntinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

-Do no use for diaper rash. Consult a doctor.

Keep out of the Reach of Children

Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Purpose

Antipruritic (Anti-itch)

Directions

-Shake will before using.

-For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.

-For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a ddoctor.

-Store away from excessive heat or cold.

Inactive Ingredients

Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Laureth Sulfate, Stearyl Alcohol, Simethicone, Xanthan Gum

Questions?

Questions? Please call (800) 423-2341

Uses

For the temporary relief of minor skin irritations, inflamaations, itching and rashes caused by:

-insect bites

-eczema

-psoriasis

-soaps

-detergents

-cosmetics,

-jewelry,

-poison oak,

-poison sumac

-Other uses of this product should be undertaken only under the advice and supervision of a doctor.

Warnings

For external use only.

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Package Label. Principal Display Panel

INGREDIENTS AND APPEARANCE

AQUANIL HC 
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0096-0732
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0096-0732-04	118 g in 1 BOTTLE; Type 0: Not a Combination Product	01/08/1995
2	NDC: 0096-0732-15	16 g in 1 BOTTLE; Type 0: Not a Combination Product	01/08/1995

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/08/1995

Labeler - Person and Covey (008482473)

Establishment
Name	Address	ID/FEI	Business Operations
Person and Covey		008482473	manufacture(0096-0732)