Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c
Route
TOPICAL
Published
Effective Date 2014-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Propylene Glycol Trolamine Polyethylene Glycol, Unspecified Glycerin Menthol, Unspecified Form Methylparaben Propylparaben Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-30

Description

Inactive Ingredients  aloe barbadensis leaf juice, carbomer 940, glycerin, menthol, methylparaben, polyethylene glycol 400, propylene glycol, propylparaben, triethanolamine, water


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses  for temporary relief of pain associated with

- minor burns

- sunburn

- minor cuts or scrapes

- minor skin irritations

Dosage and Administration

Directions

adults and children under 2 years of age:

- clean the affected area and gently dry

- apply to the affected area not more than 3 to 4 times daily

children udner 2 years of age: consult a physician

Description

Inactive Ingredients  aloe barbadensis leaf juice, carbomer 940, glycerin, menthol, methylparaben, polyethylene glycol 400, propylene glycol, propylparaben, triethanolamine, water

Section 44425-7

Other Information

store at room temperature 59 - 86 F (15 C - 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

- if condition worsens, or if symptoms persist for more than 7 days

or clear up and then occur again within a few days, discontinue use

of this product and consult a physician

Section 50567-7

When using this product

- avoid contact with eyes

Section 50570-1

Do not use

- in large quantities, particularly over raw surfaces

or blistered areas

Section 51727-6

Inactive Ingredients  aloe barbadensis leaf juice, carbomer 940,

glycerin, menthol, methylparaben, polyethylene glycol 400,

propylene glycol, propylparaben, triethanolamine, water

Section 51945-4

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active Ingredient

Lidocaine hydrochloride 2.5 %


Structured Label Content

Indications and Usage (34067-9)

Uses  for temporary relief of pain associated with

- minor burns

- sunburn

- minor cuts or scrapes

- minor skin irritations

Dosage and Administration (34068-7)

Directions

adults and children under 2 years of age:

- clean the affected area and gently dry

- apply to the affected area not more than 3 to 4 times daily

children udner 2 years of age: consult a physician

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 C - 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

- if condition worsens, or if symptoms persist for more than 7 days

or clear up and then occur again within a few days, discontinue use

of this product and consult a physician

Section 50567-7 (50567-7)

When using this product

- avoid contact with eyes

Section 50570-1 (50570-1)

Do not use

- in large quantities, particularly over raw surfaces

or blistered areas

Section 51727-6 (51727-6)

Inactive Ingredients  aloe barbadensis leaf juice, carbomer 940,

glycerin, menthol, methylparaben, polyethylene glycol 400,

propylene glycol, propylparaben, triethanolamine, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active Ingredient

Lidocaine hydrochloride 2.5 %


Advanced Ingredient Data


Raw Label Data

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