Family Care Anti-itch + Pain Relief Cream 0.5oz (10497)

Family Care Anti-itch + Pain Relief Cream 0.5oz (10497)
SPL v16
SPL
SPL Set ID 430b5753-3087-4cb1-bf54-0eedc3f4b1d5
Route
TOPICAL
Published
Effective Date 2014-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 mg) Pramoxine
Inactive Ingredients
Aloe Vera Leaf Carbomer 940 Glycerin Glyceryl Monostearate Isopropyl Myristate Methylparaben Methyl Salicylate Mineral Oil Polysorbate 60 Propylparaben Stearyl Alcohol Water Sodium Hydroxide Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-24
Description

Active Ingredients Purpose Menthol 1%.........................................................................Anti-itch/Topical analgesic Pramoxine HCl 1%..............................................................Anti-itch/Topical analgesic

Medication Information

Warnings and Precautions

Warnings For external use only.

Indications and Usage

Directions

  • not for prolonged use
  • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor.

Dosage and Administration

Distributed By: UNITED EXCHANGE CORPORATION

Cypress, CA 90630 USA | 1-888-645-8204

Made in China

Description

Active Ingredients Purpose Menthol 1%.........................................................................Anti-itch/Topical analgesic Pramoxine HCl 1%..............................................................Anti-itch/Topical analgesic

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
  • if redness, irritation, swelling or pain persists or increases

Section 50567-7

When using this product, avoid contact with eyes or nose.

Section 50570-1

Do not use

  • on deep or puncture wounds
  • animals bites
  • serious burns
  • large areas of the body
Section 51727-6

Inactive ingredients aloe vera leaf, carbomer 940, glycerin, glyceryl monostearate, isopropyl myristate, methyl salicylate, methylparaben, mineral oil, polysorbate 60, propylparaben, purified water, sodium hydroxide, stearyl alcohol, tocopheryl acetate

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

  • for temporary relief of pain and itching associated with:
  • minor skin irritations
  • minor cuts
  • minor burns
  • minor sunburns
  • scrapes
  • insect bites
  • rashes due to poison ivy, oak, or sumac
Section 55106-9

Active Ingredients Purpose

Menthol 1%.........................................................................Anti-itch/Topical analgesic

Pramoxine HCl 1%..............................................................Anti-itch/Topical analgesic

Structured Label Content

Indications and Usage (34067-9)

Directions

  • not for prolonged use
  • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor.

Dosage and Administration (34068-7)

Distributed By: UNITED EXCHANGE CORPORATION

Cypress, CA 90630 USA | 1-888-645-8204

Made in China

Warnings and Precautions (34071-1)

Warnings For external use only.

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
  • if redness, irritation, swelling or pain persists or increases

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes or nose.

Section 50570-1 (50570-1)

Do not use

  • on deep or puncture wounds
  • animals bites
  • serious burns
  • large areas of the body
Section 51727-6 (51727-6)

Inactive ingredients aloe vera leaf, carbomer 940, glycerin, glyceryl monostearate, isopropyl myristate, methyl salicylate, methylparaben, mineral oil, polysorbate 60, propylparaben, purified water, sodium hydroxide, stearyl alcohol, tocopheryl acetate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

  • for temporary relief of pain and itching associated with:
  • minor skin irritations
  • minor cuts
  • minor burns
  • minor sunburns
  • scrapes
  • insect bites
  • rashes due to poison ivy, oak, or sumac
Section 55106-9 (55106-9)

Active Ingredients Purpose

Menthol 1%.........................................................................Anti-itch/Topical analgesic

Pramoxine HCl 1%..............................................................Anti-itch/Topical analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:39.932805 · Updated: 2026-03-14T23:13:09.195902